Melanoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Melanoma

Estimated Enrollment:

40

Study ID:

NCT03716193

Recruitment Status:

Recruiting

Sponsor:

West Virginia University

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There is 1 Location for this study

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Todd Tenenholz
Morgantown West Virginia, 26506, United States More Info
Todd Tenenholz, MD
Contact
304-293-7227
[email protected]
Malcolm Mattes, MD
Sub-Investigator
Andrey Bobko, PhD
Sub-Investigator
Timothy Eubank, PhD
Sub-Investigator
Geraldine Jacobson, MD
Principal Investigator
Valery Khramtsov, PhD
Sub-Investigator
Mark Tseytlin, PhD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Estimated Enrollment:

40

Study ID:

NCT03716193

Recruitment Status:

Recruiting

Sponsor:


West Virginia University

How clear is this clinincal trial information?

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