Measuring oxygen levels in skin tumors using advanced technology
Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry
NA · West Virginia University · NCT03716193
This study is testing a new way to measure oxygen levels in skin tumors to see how well oxygen therapy and standard cancer treatments work together for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | West Virginia University (other) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Morgantown, West Virginia) |
| Trial ID | NCT03716193 on ClinicalTrials.gov |
What this trial studies
This study aims to measure the oxygen levels in various skin tumors to evaluate the effects of hyperoxygenation therapy and standard cancer treatments. Patients will receive standard care for their cancer while being assigned to one of four cohorts based on their treatment type. Using Electron Paramagnetic Resonance (EPR) Oximetry, the study will take measurements of tumor oxygen levels at baseline and during oxygen therapy. The goal is to demonstrate the feasibility of this method for obtaining clinically useful data on tumor oxygenation.
Who should consider this trial
Good fit: Ideal candidates include patients with a pathology-proven malignancy involving the skin that is at least 6 mm in diameter.
Not a fit: Patients with implanted devices incompatible with the study's methodology or those with specific allergic reactions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment strategies for skin cancer by providing insights into tumor oxygenation.
How similar studies have performed: While the use of EPR Oximetry is a novel approach in this context, similar studies have shown promise in measuring tumor oxygen levels.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Morgantown, West Virginia
- Todd Tenenholz — Morgantown, West Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Todd Tenenholz, MD — West Virginia University
- Study coordinator: Todd Tenenholz, MD
- Email: todd.tenenholz@hsc.wvu.edu
- Phone: 304-293-7227
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Skin Lesion, Skin Cancer, Skin Melanoma, Tumor Skin