- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03716193
Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 for which they qualify; there is no randomization and no stratification within the cohorts.
Cohort 1 - Patients who will receive definitive surgery for a primary malignancy of the skin
Cohort 2 - Patients who will receive definitive radiation (+/- concurrent systemic therapy) for a primary malignancy of the skin
Cohort 3 - Patients who will receive palliative radiation (+/- concurrent systemic therapy) for any tumor involving the skin
Cohort 4 - Patients who will receive systemic therapy alone (without radiation) for any tumor involving the skin
All patients enrolled in this study will undergo two initial measurements of their tumor oxygen level. On the first day, a small metal disc (less than 1 cm in diameter) called a SPOTChip will be placed on the surface of the tumor, and held in place using an adhesive. The patient will then be positioned (lying down or sitting) between a set of two magnets that are used to measure the oxygen level in the tumor. A small plastic oxygen detector will be placed on the skin over the tumor. These devices will be used to take a measurement of the tumor's oxygen level at baseline, then while breathing oxygen through a clear plastic facemask, and then a final time after the oxygen facemask has been removed.
After the measurements are taken, a small amount (20-50 microliters) of India ink will be injected into the tumor using a small (28-gauge) needle. The India ink will make a permanent, dark blue/black colored mark on the tumor. The ink leaves a permanent tattoo in the spot where it is injected, unless it is physically removed surgically.
The patient will return for another measurement, at least 2 days later. This measurement will use the India ink that was previously injected (described above) and there will no longer be a need to use the SPOTChip. For the India ink tumor oxygen measurement a small piece of wire (called a loop resonator) will be placed over the tumor and held in place using medical honey and saran wrap or tape. The Investigator will first take a measurement of the tumor's oxygen level at baseline, then while breathing oxygen through a clear plastic facemask, and then the mask will be taken the tumor's oxygen level will be measured as it returns to baseline.
Patients who have surgical excision of the tumor (cohort 1) will not have any further measurements after this point.
Patients who are being treated with radiation therapy (cohorts 2 & 3), will come back for weekly measurements of the tumor during treatment, followed by one additional measurement one month after they have completed the course of radiation therapy.
Patients being treated with chemotherapy, immunotherapy, or other systemic therapies without radiation (cohort 4), will come back for measurements every 3-4 weeks around the time of their regular infusion, followed by one additional measurement one month after they complete the course of systemic therapy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Todd Tenenholz, MD
- Phone Number: 304-293-7227
- Email: todd.tenenholz@hsc.wvu.edu
Study Locations
-
-
West Virginia
-
Morgantown, West Virginia, United States, 26506
- Recruiting
- Todd Tenenholz
-
Contact:
- Todd Tenenholz, MD
- Phone Number: 304-293-7227
- Email: todd.tenenholz@hsc.wvu.edu
-
Sub-Investigator:
- Malcolm Mattes, MD
-
Sub-Investigator:
- Andrey Bobko, PhD
-
Sub-Investigator:
- Timothy Eubank, PhD
-
Principal Investigator:
- Geraldine Jacobson, MD
-
Sub-Investigator:
- Valery Khramtsov, PhD
-
Sub-Investigator:
- Mark Tseytlin, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
Patients who will receive definitive surgery for a primary malignancy of the skin, will have their tumor injected with India ink for tumor marking and will be given oxygen during the measurement sessions.
|
Patients will be given oxygen via a facemask during the measurement session
|
Experimental: Cohort 2
Patients who will receive definitive radiation (+/- concurrent systemic therapy) for a primary malignancy of the skin, will have their tumor injected with India ink for tumor marking and will be given oxygen during the measurement sessions.
|
Patients will be given oxygen via a facemask during the measurement session
|
Experimental: Cohort 3
Patients who will receive palliative radiation (+/- concurrent systemic therapy) for any tumor involving the skin, will have their tumor injected with India ink for tumor marking and will be given oxygen during the measurement sessions.
|
Patients will be given oxygen via a facemask during the measurement session
|
Experimental: Cohort 4
Patients who will receive systemic therapy alone (without radiation) for any tumor involving the skin, will have their tumor injected with India ink for tumor marking and will be given oxygen during the measurement sessions.
|
Patients will be given oxygen via a facemask during the measurement session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the change in oxygenation of cutaneous tumors from hyperoxygenation therapy during the standard therapy for the disease
Time Frame: From the first oxygen measurement to one month after the completing standard therapy
|
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.
|
From the first oxygen measurement to one month after the completing standard therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To characterize temporal variations in oxygenation of cutaneous tumors over a course of local radiation therapy and/or systemic chemotherapy or immunotherapy
Time Frame: From the first oxygen measurement to one month after the completing standard therapy
|
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.
|
From the first oxygen measurement to one month after the completing standard therapy
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Todd Tenenholz, MD, West Virginia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1804069724
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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