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[Duplicate Record to NCT03716193] Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry
Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This protocol is designed to demonstrate the clinical feasibility of using in vivo EPR oximetry to obtain clinically useful measurements of tumor oximetry from cancer patients. By taking measurements of a variety of tumor types undergoing a variety of treatments, we will gain valuable information towards assessing our underlying hypothesis that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, especially radiation therapy, so that the therapy is applied in a way that maximizes the therapeutic ratio. All patients in this study will receive standard of care therapy for their cancer at the discretion of their treating physician(s). All subjects will be assigned to one of the four cohorts below for which they qualify;there is no randomization and no stratification within the cohorts. All measurements will be carried out before, during and after hyperoxygenation therapy * Not all tumor's may be amenable to the SPOTChip or India ink measurements. Similarly, some patients may refuse one or the other. In either of these cases, measurements may still be made with only one of the two probes.
- For patients in whom measurements are being made while on systemic therapy, the goal of the systemic therapy may be neoadjuvant in curative patients or palliative in metastatic patients.
- If patients receive chemotherapy at intervals of less than q3 weeks, oximetry measurements should still only be taken at 3-4 week intervals with every other cycle. Patients on systemic therapy for prolonged. The duration of the EPR oximetry measurements will vary t depending on the type of therapy a given patient receives (which determines the cohort they are in). Patients who undergo pre-operative EPR oximetry measurements will not have any follow-up measurements after surgery since the tumor has been excised. Patients who undergo radiation or systemic therapy will have EPR oximetry measurements during treatment, 1 month after completing radiation or systemic therapy and none thereafter. Adverse events specifically related to the India ink injection and EPR oximetry measurements will be followed until resolution, stabilization, or until it has been determined that study participation is not the cause. Adverse events related to cancer-directed therapies (e.g. radiation or systemic therapy) will not be monitored on this study.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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West Virginia
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Morgantown, West Virginia, Verenigde Staten, 26506
- WVU Medicine Department of Radiation Oncology
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Man or woman age 18-90
- Pathology-proven (histology or cytology) malignancy of any histology and site of origin
- Visible tumor (primary or metastasis) involving the skin of at least 6 mm in diameter.
- Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
- Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
The presence of any of the following will exclude a subject from study enrollment.
- Implanted electric, magnetic or mechanically activated devices like a pacemaker, defibrillator, nerve stimulator, cochlear implant or portable infusion pump. Also individuals who have any non-MRI compatible implants.
- Individuals who have a ferromagnetic foreign body located in their body.
- Prior adverse reaction to a charcoal product (e.g., a local hypersensitive response from a black tattoo or from ingestion of activated charcoal)
- Prior adverse reaction to gum Arabic, which is an ingredient in the India ink.
- Prior allergic reaction to medical adhesives.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or lactating women. There is no known harm to the woman or her fetus from participating; this is precautionary only.
- Most recent systolic blood pressure < 90 mmHg, or diastolic blood pressure < 60 mmHg, or heart rate < 50 beats per minute, or heart rate > 100 beats per minute.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Ander: Cohort 1
Patients who will receive definitive surgery for a primary malignancy of the skin.
|
The India ink we propose to use in this study consists of 20-50 μL of Carlo Erba India ink injected in subcutaneous or submucosal tissue.
This ink (referred to herein as Carlo Erba ink or CE ink or India ink) is based on a paramagnetic black pigment: purified and depyrogenated charcoal manufactured by Carlo Erba that is prepared as a sterile ink using the protocol developed at the lab of Bernard Gallez.
The India ink will be injected subdermally into the tumor.
Andere namen:
The SPOTChip is made in the form of a thin, circular in shape, disc/film having a diameter of 6-mm.
After placing the SPOTChip on the tumor, it is covered with an oxygen barrier material secured to the skin by an FDA approved medical transfer adhesive.
Andere namen:
|
Ander: Cohort 2
Patients who will receive definitive radiation (+/- concurrent systemic therapy) for a primary malignancy of the skin
|
The India ink we propose to use in this study consists of 20-50 μL of Carlo Erba India ink injected in subcutaneous or submucosal tissue.
This ink (referred to herein as Carlo Erba ink or CE ink or India ink) is based on a paramagnetic black pigment: purified and depyrogenated charcoal manufactured by Carlo Erba that is prepared as a sterile ink using the protocol developed at the lab of Bernard Gallez.
The India ink will be injected subdermally into the tumor.
Andere namen:
The SPOTChip is made in the form of a thin, circular in shape, disc/film having a diameter of 6-mm.
After placing the SPOTChip on the tumor, it is covered with an oxygen barrier material secured to the skin by an FDA approved medical transfer adhesive.
Andere namen:
|
Ander: Cohort 3
Patients who will receive palliative radiation (+/-concurrent systemic therapy) for any tumor involving the skin.
|
The India ink we propose to use in this study consists of 20-50 μL of Carlo Erba India ink injected in subcutaneous or submucosal tissue.
This ink (referred to herein as Carlo Erba ink or CE ink or India ink) is based on a paramagnetic black pigment: purified and depyrogenated charcoal manufactured by Carlo Erba that is prepared as a sterile ink using the protocol developed at the lab of Bernard Gallez.
The India ink will be injected subdermally into the tumor.
Andere namen:
The SPOTChip is made in the form of a thin, circular in shape, disc/film having a diameter of 6-mm.
After placing the SPOTChip on the tumor, it is covered with an oxygen barrier material secured to the skin by an FDA approved medical transfer adhesive.
Andere namen:
|
Ander: Cohort 4
Patients who will receive systemic therapy alone (without radiation) for any tumor involving the skin.
|
The India ink we propose to use in this study consists of 20-50 μL of Carlo Erba India ink injected in subcutaneous or submucosal tissue.
This ink (referred to herein as Carlo Erba ink or CE ink or India ink) is based on a paramagnetic black pigment: purified and depyrogenated charcoal manufactured by Carlo Erba that is prepared as a sterile ink using the protocol developed at the lab of Bernard Gallez.
The India ink will be injected subdermally into the tumor.
Andere namen:
The SPOTChip is made in the form of a thin, circular in shape, disc/film having a diameter of 6-mm.
After placing the SPOTChip on the tumor, it is covered with an oxygen barrier material secured to the skin by an FDA approved medical transfer adhesive.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
To assess change in oxygenation of cutaneous tumors from hyperoxygenation therapy
Tijdsspanne: Up to 1 year
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Tumor oxygen kinetics will be measured by EPR oximetry under ambient conditions, during hyperoxygenation therapy (100% O2 administered via a non-rebreather face mask), and immediately after hyperoxygenation therapy.
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Up to 1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
To characterize temporal variations in oxygenation of cutaneous tumors over a course of local radiation therapy and/or systemic chemotherapy or immunotherapy
Tijdsspanne: Up to 1 year
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Patients will undergo weekly tumor oxygen measurements by EPR during a radiation therapy course and every 3-4 week measurements during cycles of systemic therapy.
Changes in tumor oxygen will be correlated with standard measures of response to therapy using RECIST criteria.
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Up to 1 year
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
To compare different methods of oxygenation measurement
Tijdsspanne: Up to 1 year
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EPR measurements of pO2 using India ink will be compared to cpO2easurements using SPOTChip.
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Up to 1 year
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Todd Tenenholz, MD, PhD, West Virginia University Cancer Institute
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- WVU011118
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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Klinische onderzoeken op Cutane tumoren
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Sorrento Therapeutics, Inc.IngetrokkenVaste tumor | Recidiverende vaste tumor | Refractaire tumor
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Aadi Bioscience, Inc.WervingGeavanceerde vaste tumor | Tumor | Tumor, solideVerenigde Staten
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Memorial Sloan Kettering Cancer CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten, Puerto Rico
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterWervingVaste tumor | Vaste tumor, volwassen | Vaste tumor, niet gespecificeerd, volwassenVerenigde Staten, Puerto Rico
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RemeGen Co., Ltd.VoltooidMetastatische vaste tumor | Lokaal geavanceerde vaste tumor | Inoperabele vaste tumorAustralië
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Baodong QinWervingRefractaire tumor | Zeldzame tumorChina
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National Health Research Institutes, TaiwanNational Cheng-Kung University HospitalWerving
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Elpiscience Biopharma, Ltd.Shanghai Junshi Bioscience Co., Ltd.WervingNeoplasmata | Vaste tumor | Kwaadaardige tumorChina
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The First Affiliated Hospital of Xiamen UniversityWervingVaste tumor | Tumor | Positron-emissietomografieChina
Klinische onderzoeken op India Ink measurement
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Nuwacell Biotechnologies Co., Ltd.Nog niet aan het werven
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Brigham and Women's HospitalE-ink corporationOnbekendSpoedgevallen | Covid19 | Tevredenheid, patiënt | Tevredenheid | Vrijgeven van informatieVerenigde Staten
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Yonsei UniversityVoltooidCerebrale parese | Kinderen met hersenletselKorea, republiek van
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Zagazig UniversityVoltooidIntralesionaal versus intramusculair hepatitis B-vaccin voor meerdere veelvoorkomende wrattenEgypte
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Medistim ASANog niet aan het wervenCardiale bypassoperatie (CABG)
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Abbott NutritionVoltooidType 2 diabetesVerenigde Staten
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London School of Hygiene and Tropical MedicineSangath; University College, London; University of Liverpool; Human Development Research...OnbekendDood | Depressie, postpartum | Kinder ontwikkeling | Groei; Stunting, voedingswaardeIndië, Pakistan
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NSCB Medical CollegeVoltooidNormaal Gezond Termijn Passend-voor-date PasgeborenIndië
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All India Institute of Medical Sciences, New DelhiIndian Council of Medical ResearchVoltooid
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Thinq Pharma-CRO Pte. Ltd.Unique Pharmaceuticals Ltd, India; THINQ Pharma CRO Ltd.Onbekend