Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry

NCT03716193 | Terminated DMC

• 1 other identifier: 1804069724
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Skin Lesion; Skin Cancer; Skin Melanoma; Tumor Skin

Outcome Measures

Primary Outcomes (1)

• Assess the change in oxygenation of cutaneous tumors from hyperoxygenation therapy during the standard therapy for the disease

  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 Outcomes (1)

• To characterize temporal variations in oxygenation of cutaneous tumors over a course of local radiation therapy and/or systemic chemotherapy or immunotherapy

  From the first oxygen measurement to one month after the completing standard therapy

Study Arms (4)

Cohort 1

EXPERIMENTAL

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.

Other: Oxygen

Cohort 2

EXPERIMENTAL

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.

Other: Oxygen

Cohort 3

EXPERIMENTAL

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.

Other: Oxygen

Cohort 4

EXPERIMENTAL

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.

Other: Oxygen

Interventions

Oxygen OTHER

Patients will be given oxygen via a facemask during the measurement session

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead
• Mary Babb Randolph Cancer Center at West Virginia University Hospitals: collaborator
• West Virginia Clinical and Translational Science Institute: collaborator

Study Sites (1)

Todd Tenenholz

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Skin Neoplasms; Melanoma

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Todd Tenenholz, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Four cohorts based on standard treatment will be given the same intervention

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 23, 2018
• Study Start: October 17, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)