- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03321903
EPR Tumor Oximetry With CE India Ink
Tumor Oximetry Using Electron Paramagnetic Resonance (EPR) With India Ink (Using Carbon Particulates From Carlo Erba [CE])
It has been well established that malignant tumors tend to have low levels of oxygen and that tumors with very low levels of oxygen are more resistant to radiotherapy and other treatments, such as chemotherapy and immunotherapy. Previous attempts to improve response to therapy by increasing the oxygen level of tissues have had disappointing results and collectively have not led to changing clinical practice. Without a method to measure oxygen levels in tumors or the ability to monitor over time whether tumors are responding to methods to increase oxygen during therapy, clinician's reluctance to use oxygen therapy in usual practice is not surprising.
The hypothesis underlying this research is that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, including combined therapy, and to minimize normal tissue side effects or complications. Because studies have found that tumors vary both in their initial levels of oxygen and exhibit changing patterns during growth and treatment, we propose to monitor oxygen levels in tumors and their responsiveness to hyperoxygenation procedures. Such knowledge about oxygen levels in tumor tissues and their responsiveness to hyper-oxygenation could potentially be used to select subjects for particular types of treatment, or otherwise to adjust routine care for patients known to have hypoxic but unresponsive tumors in order to improve their outcomes.
The overall objectives of this study are to establish the clinical feasibility and efficacy of using in vivo electron paramagnetic resonance (EPR) oximetry-a technique related to magnetic resonance imaging (MRI)-to obtain direct and repeated measurements of clinically useful information about tumor tissue oxygenation in specific groups of subjects with the same types of tumors, and to establish the clinical feasibility and efficacy of using inhalation of enriched oxygen to gain additional clinically useful information about responsiveness of tumors to hyper-oxygenation. Two devices are used: a paramagnetic charcoal suspension (Carlo Erba India ink) and in vivo EPR oximetry to assess oxygen levels. The ink is injected and becomes permanent in the tissue at the site of injection unless removed; thereafter, the in vivo oximetry measurements are noninvasive and can be repeated indefinitely.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study design uses consecutively enrolled patients. Patients can participate as long as they are willing, fit the criteria for being assigned to a cohort, and the India ink spot remains measurable by EPR. Patients whose ink spot is resected during usual care and who do not have or are not willing to obtain additional injections will be withdrawn. Otherwise, patients can be re-measured using the previously injected ink at any time during the course of the study.
The study is split into four cohorts, with a minimum of 1-5 patients expected to be enrolled annually in each cohort, and a total of approximately 10 subjects expected for each cohort. The cohorts are defined by the type of tumor and by scenarios when our measurements will be made relative to the patient's standard therapies: 1) intraoral tumors with planned resection and adjuvant radiation therapy; 2) cutaneous malignant tumors receiving surgical resection only, receiving radiation therapy only, or receiving both surgical resection and adjuvant radiation therapy; 3) breast tumor receiving radiation therapy following surgery; and 4) other tumors receiving radiation therapy. The diagnosis for patients in all cases assumes that an eligible tumor (or the postsurgical area receiving radiation) occurs within approximately one-half centimeter of the surface, as determined by physical exam or imaging if available. All potentially eligible subjects are approached by their treating physician; those who agree to be contacted and are subsequently consented are assigned to the cohort for which they qualify. There is no randomization and no stratification within the cohorts.
Our interest in in situ tumor oxygenation relates to the clinical need to measure oxygen in tumors prior to therapy, to understand tumor oxygen dynamics over the course of therapy, and to assess the effectiveness of oxygen modulation therapy during treatment. Our interest in the postsurgical radiation field relates to the clinical need to understand whether the temporal dynamics of oxygen within the postsurgical radiation field has the potential to enhance the effectiveness of adjuvant therapies, and to understand how changes in short and long term oxygenation within the postsurgical radiation field may facilitate diminishment of late side effects from surgery and/or radiotherapy.
Following enrollment in the study, each subject will receive an initial placement of one or more geographically separate injections of India ink into the tissue of interest (i.e., tumor and/or tumor bed and/or adjacent tissue) using the established procedures for the injection of the ink. The subject is expected to agree to periodic measurements of all injection sites (unless the ink injection has been surgically removed); the subject will be told to expect six or more visits for measurements during treatment, but must agree to have at least one measurement per injection site. Each measurement will typically consist of 3 ten minute consecutive periods during which the subject initially breathes room air, then 100% oxygen delivered through a non-rebreather face mask followed by a period breathing room air.
Patients will be evaluated during clinical and oximetry appointments with respect to the presence of any adverse events.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Hampshire
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Lebanon, New Hampshire, United States, 03766
- Dartmouth-Hitchcock Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subject must be capable of giving informed consent or has an acceptable surrogate capable of giving consent on behalf of the subject.
Subject has an eligible tumor that is within 5 mm of the surface (either skin or mucosa) or has had a tumor removed with a tumor bed that is within 5 mm of the surface.
Eligible tumors types:
- Intraoral tumors: squamous cell carcinoma (SCC), melanoma;
- Primary cutaneous tumors (including, but not limited to): SCC, basal cell carcinoma (BCC,) melanoma;
- Breast malignancies post surgery;
- Other tumors: any tumor within 5 mm of the surface and with planned radiation therapy.
Exclusion Criteria:
- Previous adverse reaction to a charcoal product e.g., a local hypersensitive response from a black tattoo or from ingestion of activated charcoal
- Previous adverse reaction to the suspending agent
- Subject has a pacemaker that is not known to be MRI compatible
- Subject has a non-removable implant or device with metal that is not known to be MRI compatible
- Subject is pregnant or has a likelihood for becoming pregnant during the basic study timeframe.
Note: There is no known harm to the woman or her fetus from participating; this is precautionary only.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1: Intraoral Squamous Cell Carcinomas
Intraoral squamous cell carcinomas that are resected and receive adjuvant radiation therapy.
These patients may receive a Carlo Erba Ink injection before surgical tumor resection, after tumor resection (in the postsurgical radiation field), or in both instances.
Patients whose tumor is within 5 mm of the surface will have injections of India ink into the tumor itself and measurements made in the tumor prior to surgery.
Patients whose tumor is deeper than 5 mm of the surface could participate only in the measurements of the postsurgical radiation field.
EPR Oximetry measurements will be made in the tumor and/or, if applicable, over the course of radiation in the postsurgical radiation field as appropriate.
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Carlo Erba India ink is used in this study as a paramagnetic oxygen sensor that is injected into tissue, and which, when measured using EPR Oximetry, can provide sensitive, repeated, and direct measurements of tissue oxygen.
Each study participant will receive at least one ink injection of 20-50µL of Carlo Erba India Ink.
The ink injection will occur within 5mm of the body surface (i.e., skin or mucosa), and may be injected into tumor, postsurgical field of radiation, and/or adjacent normal tissue.
Carlo Erba Ink is an aqueous suspension composed of charcoal powder, water for injection, and a suspending agent.
Carlo Erba is the name of the manufacturer that supplies the charcoal.
Other Names:
An oximetry measurement visit consists of ~ 30 minutes of continuous scans of tissue oxygen in vivo, using an oxygen sensor (i.e., India ink) injected into the tumor that is noninvasively scanned using EPR oximetry.
Scans, converted into measurements of pO2, characterize the current tumor oxygen level at: (1) 'steady state' (while breathing room air), 2) response to hyperoxygenation therapy (inhaling oxygen-enriched air for 10 min), and 3) response to resuming inhaling room air.
EPR measurements are repeated noninvasively throughout radiation or chemotherapy, to examine changes.
The minimum number of visits depends on the patient's cohort; all may have additional measurements.
If the ink injection is not surgically removed, EPR oximetry measurements can be repeated indefinitely.
Other Names:
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2: Cutaneous Malignant Tumors
Patients with primary cutaneous malignant tumors (including but not limited to squamous cell carcinoma, basal cell carcinoma, or melanoma) whose tumor is within 5 mm of the surface and whose treatment plan includes surgical resection and/or postsurgical radiation therapy.
These patients may receive a Carlo Erba Ink injection before surgical tumor resection, after tumor resection (in the postsurgical radiation field), in both the tumor and the postsurgical radiation field, or in the tumor prior to radiation therapy.
EPR Oximetry measurements will be made in the tumor and/or, if applicable, over the course of radiation in the tumor or postsurgical radiation field as appropriate.
|
Carlo Erba India ink is used in this study as a paramagnetic oxygen sensor that is injected into tissue, and which, when measured using EPR Oximetry, can provide sensitive, repeated, and direct measurements of tissue oxygen.
Each study participant will receive at least one ink injection of 20-50µL of Carlo Erba India Ink.
The ink injection will occur within 5mm of the body surface (i.e., skin or mucosa), and may be injected into tumor, postsurgical field of radiation, and/or adjacent normal tissue.
Carlo Erba Ink is an aqueous suspension composed of charcoal powder, water for injection, and a suspending agent.
Carlo Erba is the name of the manufacturer that supplies the charcoal.
Other Names:
An oximetry measurement visit consists of ~ 30 minutes of continuous scans of tissue oxygen in vivo, using an oxygen sensor (i.e., India ink) injected into the tumor that is noninvasively scanned using EPR oximetry.
Scans, converted into measurements of pO2, characterize the current tumor oxygen level at: (1) 'steady state' (while breathing room air), 2) response to hyperoxygenation therapy (inhaling oxygen-enriched air for 10 min), and 3) response to resuming inhaling room air.
EPR measurements are repeated noninvasively throughout radiation or chemotherapy, to examine changes.
The minimum number of visits depends on the patient's cohort; all may have additional measurements.
If the ink injection is not surgically removed, EPR oximetry measurements can be repeated indefinitely.
Other Names:
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3: Breast Cancers
Breast cancer patients whose treatment plan includes surgical resection followed by radiation therapy.
All patients who receive a surgical resection will receive a Carlo Erba Ink injection in the radiation field after sufficient healing has occurred to the area to be injected, as determined in consultation with the treating physicians, and using topical anesthetic or local anesthetic, if the patient so desires.
All patients in this cohort will be expected to agree to a minimum of one EPR Oximetry measurement in the planned radiation field prior to radiation and a minimum of one measurement made over the course of radiation therapy.
|
Carlo Erba India ink is used in this study as a paramagnetic oxygen sensor that is injected into tissue, and which, when measured using EPR Oximetry, can provide sensitive, repeated, and direct measurements of tissue oxygen.
Each study participant will receive at least one ink injection of 20-50µL of Carlo Erba India Ink.
The ink injection will occur within 5mm of the body surface (i.e., skin or mucosa), and may be injected into tumor, postsurgical field of radiation, and/or adjacent normal tissue.
Carlo Erba Ink is an aqueous suspension composed of charcoal powder, water for injection, and a suspending agent.
Carlo Erba is the name of the manufacturer that supplies the charcoal.
Other Names:
An oximetry measurement visit consists of ~ 30 minutes of continuous scans of tissue oxygen in vivo, using an oxygen sensor (i.e., India ink) injected into the tumor that is noninvasively scanned using EPR oximetry.
Scans, converted into measurements of pO2, characterize the current tumor oxygen level at: (1) 'steady state' (while breathing room air), 2) response to hyperoxygenation therapy (inhaling oxygen-enriched air for 10 min), and 3) response to resuming inhaling room air.
EPR measurements are repeated noninvasively throughout radiation or chemotherapy, to examine changes.
The minimum number of visits depends on the patient's cohort; all may have additional measurements.
If the ink injection is not surgically removed, EPR oximetry measurements can be repeated indefinitely.
Other Names:
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4: Other tumors
Other tumors within 5 mm of the surface, whose planned treatment includes radiotherapy of the tumor and does not include a planned resection of the tumor.
As these other qualifying malignancies are expected to occur only rarely, they will be grouped into a single cohort despite potential varied histology.
These patients will receive a Carlo Erba Ink injection in their tumor prior to radiation therapy.
All patients in this cohort will be expected to agree to a minimum of one EPR Oximetry measurement in the planned radiation field prior to radiation and a minimum of one measurement made over the course of radiation therapy.
|
Carlo Erba India ink is used in this study as a paramagnetic oxygen sensor that is injected into tissue, and which, when measured using EPR Oximetry, can provide sensitive, repeated, and direct measurements of tissue oxygen.
Each study participant will receive at least one ink injection of 20-50µL of Carlo Erba India Ink.
The ink injection will occur within 5mm of the body surface (i.e., skin or mucosa), and may be injected into tumor, postsurgical field of radiation, and/or adjacent normal tissue.
Carlo Erba Ink is an aqueous suspension composed of charcoal powder, water for injection, and a suspending agent.
Carlo Erba is the name of the manufacturer that supplies the charcoal.
Other Names:
An oximetry measurement visit consists of ~ 30 minutes of continuous scans of tissue oxygen in vivo, using an oxygen sensor (i.e., India ink) injected into the tumor that is noninvasively scanned using EPR oximetry.
Scans, converted into measurements of pO2, characterize the current tumor oxygen level at: (1) 'steady state' (while breathing room air), 2) response to hyperoxygenation therapy (inhaling oxygen-enriched air for 10 min), and 3) response to resuming inhaling room air.
EPR measurements are repeated noninvasively throughout radiation or chemotherapy, to examine changes.
The minimum number of visits depends on the patient's cohort; all may have additional measurements.
If the ink injection is not surgically removed, EPR oximetry measurements can be repeated indefinitely.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of oxygen levels in tissues in response to hyperoxic therapy
Time Frame: From time of ink injection to the time the ink is removed through surgical resection. This can range from days to years, or until the study's completion of enrollment, anticipated in 2020.
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This study will assess whether the addition of hyperoxic therapy (100% oxygen delivered through a non-rebreather face mask) will increase the oxygen level of a tumor or tumor bed by > 5 mm Hg using EPR oximetry.
Tumor oxygen values will be reported in millimeters of mercury (mmHg).
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From time of ink injection to the time the ink is removed through surgical resection. This can range from days to years, or until the study's completion of enrollment, anticipated in 2020.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterize oxygen changes in tumor beds throughout the course of radiation therapy
Time Frame: From time of ink injection through the completion of radiation therapy; an average of 4 months.
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This outcome will measure oxygen in the post-surgical tissue throughout the course of radiation therapy using EPR oximetry.
Tissue oxygen values will be reported in millimeters of mercury (mmHg).
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From time of ink injection through the completion of radiation therapy; an average of 4 months.
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Characterize oxygen changes in tumors throughout the course of radiation therapy
Time Frame: From time of ink injection through the completion of radiation therapy; an average of 4 months.
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This outcome will measure tumor tissue oxygen throughout the course of radiation therapy using EPR oximetry.
Tissue oxygen values will be reported in millimeters of mercury (mmHg).
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From time of ink injection through the completion of radiation therapy; an average of 4 months.
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Characterize oxygen changes in tumor and tumor beds prior to radiation therapy
Time Frame: From time of ink injection through the completion of medical treatment for cancer; an average of 4 months.
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For those subjects receiving India ink injections in both the untreated tumor and in the post-surgical bed prior to radiation, we will examine patterns across these two 'states' in individual tumors, which can enhance our understanding of the relationship between the oxygen levels in the tumor and in the resulting tumor bed.
Tissue oxygen values will be reported in millimeters of mercury (mmHg).
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From time of ink injection through the completion of medical treatment for cancer; an average of 4 months.
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Characterize oxygen changes in tumor and tumor beds through the course of radiation therapy
Time Frame: From time of ink injection through the completion of medical treatment for cancer; an average of 6 months.
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For those subjects receiving India ink injections in both the untreated tumor and in the post-surgical bed while undergoing radiation therapy, we will examine patterns across these two 'states' in individual tumors, which can enhance our understanding of the relationship between the oxygen levels in the tumor and in the resulting tumor bed.
Tissue oxygen values will be reported in millimeters of mercury (mmHg).
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From time of ink injection through the completion of medical treatment for cancer; an average of 6 months.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tissue Histology
Time Frame: Approximately 30 days post-surgical excision of the tumor
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For those subjects whose tumor is resected along with the tissue containing the India ink carbon particles as a part of their usual care, the tissue at the site of the injection will be submitted for processing with standard pathology procedures.
Tissue sections spanning the injection site(s) will be evaluated for the extent and mechanism of dispersion and for the presence of acute or chronic inflammation or other tissue reaction (scar, fibrosis, capsule formation, or other).
The tissue will be assessed as to whether the reaction observed is as expected for ink injections.
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Approximately 30 days post-surgical excision of the tumor
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip E Schaner, M.D., Ph.D., Dartmouth-Hitchcock Medical Center
Publications and helpful links
General Publications
- Bacic G, Liu KJ, O'Hara JA, Harris RD, Szybinski K, Goda F, Swartz HM. Oxygen tension in a murine tumor: a combined EPR and MRI study. Magn Reson Med. 1993 Nov;30(5):568-72. doi: 10.1002/mrm.1910300507.
- Baudelet C, Gallez B. How does blood oxygen level-dependent (BOLD) contrast correlate with oxygen partial pressure (pO2) inside tumors? Magn Reson Med. 2002 Dec;48(6):980-6. doi: 10.1002/mrm.10318.
- Brizel DM, Scully SP, Harrelson JM, Layfield LJ, Dodge RK, Charles HC, Samulski TV, Prosnitz LR, Dewhirst MW. Radiation therapy and hyperthermia improve the oxygenation of human soft tissue sarcomas. Cancer Res. 1996 Dec 1;56(23):5347-50.
- Brizel DM, Sibley GS, Prosnitz LR, Scher RL, Dewhirst MW. Tumor hypoxia adversely affects the prognosis of carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 1997 May 1;38(2):285-9. doi: 10.1016/s0360-3016(97)00101-6.
- Charlier N, Beghein N, Gallez B. Development and evaluation of biocompatible inks for the local measurement of oxygen using in vivo EPR. NMR Biomed. 2004 Aug;17(5):303-10. doi: 10.1002/nbm.902.
- Chaplin DJ, Horsman MR. Tumor blood flow changes induced by chemical modifiers of radiation response. Int J Radiat Oncol Biol Phys. 1992;22(3):459-62. doi: 10.1016/0360-3016(92)90853-a.
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- Dewhirst MW, Poulson JM, Yu D, Sanders L, Lora-Michiels M, Vujaskovic Z, Jones EL, Samulski TV, Powers BE, Brizel DM, Prosnitz LR, Charles HC. Relation between pO2, 31P magnetic resonance spectroscopy parameters and treatment outcome in patients with high-grade soft tissue sarcomas treated with thermoradiotherapy. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):480-91. doi: 10.1016/j.ijrobp.2004.06.211.
- Dunn JF, Ding S, O'Hara JA, Liu KJ, Rhodes E, Weaver JB, Swartz HM. The apparent diffusion constant measured by MRI correlates with pO2 in a RIF-1 tumor. Magn Reson Med. 1995 Oct;34(4):515-9. doi: 10.1002/mrm.1910340405.
- Flood AB, Satinsky VA, Swartz HM. Comparing the Effectiveness of Methods to Measure Oxygen in Tissues for Prognosis and Treatment of Cancer. Adv Exp Med Biol. 2016;923:113-120. doi: 10.1007/978-3-319-38810-6_15.
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- Gallez B, Swartz HM. In vivo EPR: when, how and why? NMR Biomed. 2004 Aug;17(5):223-5. doi: 10.1002/nbm.913.
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- Haga T, Hirata H, Lesniewski P, Rychert KM, Williams BB, Flood AN, Swartz HM. L-band surface-coil resonator with voltage-control impedance-matching for EPR tooth dosimetry. Concepts in Magnetic Resonance Part B: Magnetic Resonance Engineering. 2013 Feb 1;43(1):32-40.2013).
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- Jordan BF, Gregoire V, Demeure RJ, Sonveaux P, Feron O, O'Hara J, Vanhulle VP, Delzenne N, Gallez B. Insulin increases the sensitivity of tumors to irradiation: involvement of an increase in tumor oxygenation mediated by a nitric oxide-dependent decrease of the tumor cells oxygen consumption. Cancer Res. 2002 Jun 15;62(12):3555-61.
- Jordan BF, Misson P, Demeure R, Baudelet C, Beghein N, Gallez B. Changes in tumor oxygenation/perfusion induced by the no donor, isosorbide dinitrate, in comparison with carbogen: monitoring by EPR and MRI. Int J Radiat Oncol Biol Phys. 2000 Sep 1;48(2):565-70. doi: 10.1016/s0360-3016(00)00694-5.
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- Lartigau E, Lusinchi A, Eschwege F, Guichard M. Tumor oxygenation: the Institut Gustave Roussy experience. In: Vaupel P, Kelleher DK (ed). Tumor hypoxia pathophysiology, clinical significance and therapeutic perspectives. Stuttgart, Germany: Wissenschaftliche Verlagsgesellschaft mbH. 1999:47-52.
- Liu KJ, Gast P, Moussavi M, Norby SW, Vahidi N, Walczak T, Wu M, Swartz HM. Lithium phthalocyanine: a probe for electron paramagnetic resonance oximetry in viable biological systems. Proc Natl Acad Sci U S A. 1993 Jun 15;90(12):5438-42. doi: 10.1073/pnas.90.12.5438.
- Nakashima T, Goda F, Jiang J, Shima T, Swartz HM. Use of EPR oximetry with India ink to measure the pO2 in the liver in vivo in mice. Magn Reson Med. 1995 Dec;34(6):888-92. doi: 10.1002/mrm.1910340614.
- Nilges MJ, Walczak T, Swartz HM. GHz in vivo ESR spectrometer operating with a surface probe. Phys. Med. 1989;5:195-201.
- Nordsmark M, Alsner J, Keller J, Nielsen OS, Jensen OM, Horsman MR, Overgaard J. Hypoxia in human soft tissue sarcomas: adverse impact on survival and no association with p53 mutations. Br J Cancer. 2001 Apr 20;84(8):1070-5. doi: 10.1054/bjoc.2001.1728.
- Nordsmark M, Bentzen SM, Rudat V, Brizel D, Lartigau E, Stadler P, Becker A, Adam M, Molls M, Dunst J, Terris DJ, Overgaard J. Prognostic value of tumor oxygenation in 397 head and neck tumors after primary radiation therapy. An international multi-center study. Radiother Oncol. 2005 Oct;77(1):18-24. doi: 10.1016/j.radonc.2005.06.038. Epub 2005 Aug 10.
- O'Hara JA, Goda F, Demidenko E, Swartz HM. Effect on regrowth delay in a murine tumor of scheduling split-dose irradiation based on direct pO2 measurements by electron paramagnetic resonance oximetry. Radiat Res. 1998 Nov;150(5):549-56.
- O'Hara JA, Goda F, Liu KJ, Bacic G, Hoopes PJ, Swartz HM. The pO2 in a murine tumor after irradiation: an in vivo electron paramagnetic resonance oximetry study. Radiat Res. 1995 Nov;144(2):222-9.
- O'Hara JA, Hou H, Demidenko E, Springett RJ, Khan N, Swartz HM. Simultaneous measurement of rat brain cortex PtO2 using EPR oximetry and a fluorescence fiber-optic sensor during normoxia and hyperoxia. Physiol Meas. 2005 Jun;26(3):203-13. doi: 10.1088/0967-3334/26/3/006. Epub 2005 Feb 25.
- O'Hara JA, Khan N, Hou H, Wilmo CM, Demidenko E, Dunn JF, Swartz HM. Comparison of EPR oximetry and Eppendorf polarographic electrode assessments of rat brain PtO2. Physiol Meas. 2004 Dec;25(6):1413-23. doi: 10.1088/0967-3334/25/6/007.
- Petryakov SV, Schreiber W, Kmiec MM, Williams BB, Swartz HM. Surface Dielectric Resonators for X-band EPR Spectroscopy. Radiat Prot Dosimetry. 2016 Dec;172(1-3):127-132. doi: 10.1093/rpd/ncw167. Epub 2016 Jul 15.
- Salikhov I, Hirata H, Walczak T, Swartz HM. An improved external loop resonator for in vivo L-band EPR spectroscopy. J Magn Reson. 2003 Sep;164(1):54-9. doi: 10.1016/s1090-7807(03)00175-7.
- Salikhov IK, Swartz HM. Measurement of specific absorption rate for clinical EPR at 1200 MHz. Applied Magnetic Resonance. 2005 Jun 1;29(2):287-91.
- Smirnov AI, Norby SW, Clarkson RB, Walczak T, Swartz HM. Simultaneous multi-site EPR spectroscopy in vivo. Magn Reson Med. 1993 Aug;30(2):213-20. doi: 10.1002/mrm.1910300210.
- Smirnov AI, Norby SW, Walczak T, Liu KJ, Swartz HM. Physical and instrumental considerations in the use of lithium phthalocyanine for measurements of the concentration of the oxygen. J Magn Reson B. 1994 Feb;103(2):95-102. doi: 10.1006/jmrb.1994.1016.
- Swartz HM. Using EPR to measure a critical but often unmeasured component of oxidative damage: oxygen. Antioxid Redox Signal. 2004 Jun;6(3):677-86. doi: 10.1089/152308604773934440.
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- Swartz HM. Potential Medical (Clinical) Applications of EPR: Overview & Perspectives. InIn Vivo EPR (ESR) 2003 (pp. 599-621). Springer US.
- Swartz HM, Clarkson RB. The measurement of oxygen in vivo using EPR techniques. Phys Med Biol. 1998 Jul;43(7):1957-75. doi: 10.1088/0031-9155/43/7/017.
- Swartz HM, Dunn JF. Measurements of oxygen in tissues: overview and perspectives on methods. Adv Exp Med Biol. 2003;530:1-12. doi: 10.1007/978-1-4615-0075-9_1.
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- Swartz HM, Halpern H. EPR studies of living animals and related model systems (in vivo EPR). InBiological magnetic resonance 2002 (pp. 367-404). Springer US.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Neoplasms, Squamous Cell
- Neoplasms, Basal Cell
- Neoplasms
- Breast Neoplasms
- Head and Neck Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Skin Neoplasms
- Carcinoma, Basal Cell
- Physiological Effects of Drugs
- Protective Agents
- Antidotes
- Charcoal
Other Study ID Numbers
- 29880 D17008
- P01CA190193 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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