Clinical trial · Interventional
Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry
NCT03716193CI-TRIAL-00104236terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated March 22, 2022 due to COVID-19 pandemic
Summary
Brief summary (as posted)
This protocol will take measurements of a variety of tumors involving the skin in order to assess changes in tumor oxygen from hyperoxygenation therapy and standard cancer-directed treatments, to demonstrate the clinical feasibility of using in vivo Electron Paramagnetic Resonance (EPR) Oximetry to obtain clinically useful measurements of tumor oxygen levels from cancer patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Skin Lesion | — | UNRESOLVED | — |
| Skin Melanoma | Cutaneous Melanoma | ALIAS | 0.90 |
| Tumor Skin | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxygen | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- 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.
- interventionNames
- Other: Oxygen
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- 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.
- interventionNames
- Other: Oxygen
- type
- EXPERIMENTAL
- label
- Cohort 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.