[Duplicate Record to NCT03716193] Measurement of the Partial Pressure of Oxygen in Cutaneous Tumors Using Electron Paramagnetic Resonance (EPR) Oximetry

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

Oxygen has a critical role in the metabolism of tumors and normal tissues and is a key determinant of sensitivity of tissues to ionizing radiation. Knowledge of the relationship between the partial pressure of oxygen (pO2) and radiation sensitivity has been exploited in strategies to enhance oxygenation or to sensitize hypoxic cells to radiation. This study involves taking at least one measurement of the oxygen level in the patient's tumor before, during, and after breathing oxygen through a facemask. The goal of the measurements is to learn more about changes in tumor oxygen levels in response to breathing extra oxygen and standard treatments like chemotherapy and radiation therapy, so that in the future we have a better understanding of how to best use these treatments to improve their ability to fight cancer. By taking measurements of a variety of tumor types undergoing a variety of treatments, we will gain valuable information towards assessing our underlying hypothesis that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, especially radiation therapy, so that the therapy is applied in a way that maximizes the therapeutic ratio. All patients in this study will receive standard of care therapy for their cancer at the discretion of their treating physician(s).

Study Overview

• Status: Suspended
• Conditions: Cutaneous Tumors; Skin Cancers
• Intervention / Treatment: Device: India Ink measurement; Device: SPOTChip measurement

Detailed Description

This protocol is designed to demonstrate the clinical feasibility of using in vivo EPR oximetry to obtain clinically useful measurements of tumor oximetry from cancer patients. By taking measurements of a variety of tumor types undergoing a variety of treatments, we will gain valuable information towards assessing our underlying hypothesis that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, especially radiation therapy, so that the therapy is applied in a way that maximizes the therapeutic ratio. 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 below for which they qualify;there is no randomization and no stratification within the cohorts. All measurements will be carried out before, during and after hyperoxygenation therapy * Not all tumor's may be amenable to the SPOTChip or India ink measurements. Similarly, some patients may refuse one or the other. In either of these cases, measurements may still be made with only one of the two probes.

• For patients in whom measurements are being made while on systemic therapy, the goal of the systemic therapy may be neoadjuvant in curative patients or palliative in metastatic patients.
• If patients receive chemotherapy at intervals of less than q3 weeks, oximetry measurements should still only be taken at 3-4 week intervals with every other cycle. Patients on systemic therapy for prolonged. The duration of the EPR oximetry measurements will vary t depending on the type of therapy a given patient receives (which determines the cohort they are in). Patients who undergo pre-operative EPR oximetry measurements will not have any follow-up measurements after surgery since the tumor has been excised. Patients who undergo radiation or systemic therapy will have EPR oximetry measurements during treatment, 1 month after completing radiation or systemic therapy and none thereafter. Adverse events specifically related to the India ink injection and EPR oximetry measurements will be followed until resolution, stabilization, or until it has been determined that study participation is not the cause. Adverse events related to cancer-directed therapies (e.g. radiation or systemic therapy) will not be monitored on this study.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • WVU Medicine Department of Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Man or woman age 18-90
• 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
• Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment.

• 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.
• Most recent systolic blood pressure < 90 mmHg, or diastolic blood pressure < 60 mmHg, or heart rate < 50 beats per minute, or heart rate > 100 beats per minute.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort 1; Patients who will receive definitive surgery for a primary malignancy of the skin.	Device: India Ink measurement; The India ink we propose to use in this study consists of 20-50 μL of Carlo Erba India ink injected in subcutaneous or submucosal tissue. This ink (referred to herein as Carlo Erba ink or CE ink or India ink) is based on a paramagnetic black pigment: purified and depyrogenated charcoal manufactured by Carlo Erba that is prepared as a sterile ink using the protocol developed at the lab of Bernard Gallez. The India ink will be injected subdermally into the tumor.; Other Names: Carlo Erba Ink or CE Ink measurement; Device: SPOTChip measurement; The SPOTChip is made in the form of a thin, circular in shape, disc/film having a diameter of 6-mm. After placing the SPOTChip on the tumor, it is covered with an oxygen barrier material secured to the skin by an FDA approved medical transfer adhesive.; Other Names: Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement
Other: Cohort 2; Patients who will receive definitive radiation (+/- concurrent systemic therapy) for a primary malignancy of the skin	Device: India Ink measurement; The India ink we propose to use in this study consists of 20-50 μL of Carlo Erba India ink injected in subcutaneous or submucosal tissue. This ink (referred to herein as Carlo Erba ink or CE ink or India ink) is based on a paramagnetic black pigment: purified and depyrogenated charcoal manufactured by Carlo Erba that is prepared as a sterile ink using the protocol developed at the lab of Bernard Gallez. The India ink will be injected subdermally into the tumor.; Other Names: Carlo Erba Ink or CE Ink measurement; Device: SPOTChip measurement; The SPOTChip is made in the form of a thin, circular in shape, disc/film having a diameter of 6-mm. After placing the SPOTChip on the tumor, it is covered with an oxygen barrier material secured to the skin by an FDA approved medical transfer adhesive.; Other Names: Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement
Other: Cohort 3; Patients who will receive palliative radiation (+/-concurrent systemic therapy) for any tumor involving the skin.	Device: India Ink measurement; The India ink we propose to use in this study consists of 20-50 μL of Carlo Erba India ink injected in subcutaneous or submucosal tissue. This ink (referred to herein as Carlo Erba ink or CE ink or India ink) is based on a paramagnetic black pigment: purified and depyrogenated charcoal manufactured by Carlo Erba that is prepared as a sterile ink using the protocol developed at the lab of Bernard Gallez. The India ink will be injected subdermally into the tumor.; Other Names: Carlo Erba Ink or CE Ink measurement; Device: SPOTChip measurement; The SPOTChip is made in the form of a thin, circular in shape, disc/film having a diameter of 6-mm. After placing the SPOTChip on the tumor, it is covered with an oxygen barrier material secured to the skin by an FDA approved medical transfer adhesive.; Other Names: Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement
Other: Cohort 4; Patients who will receive systemic therapy alone (without radiation) for any tumor involving the skin.	Device: India Ink measurement; The India ink we propose to use in this study consists of 20-50 μL of Carlo Erba India ink injected in subcutaneous or submucosal tissue. This ink (referred to herein as Carlo Erba ink or CE ink or India ink) is based on a paramagnetic black pigment: purified and depyrogenated charcoal manufactured by Carlo Erba that is prepared as a sterile ink using the protocol developed at the lab of Bernard Gallez. The India ink will be injected subdermally into the tumor.; Other Names: Carlo Erba Ink or CE Ink measurement; Device: SPOTChip measurement; The SPOTChip is made in the form of a thin, circular in shape, disc/film having a diameter of 6-mm. After placing the SPOTChip on the tumor, it is covered with an oxygen barrier material secured to the skin by an FDA approved medical transfer adhesive.; Other Names: Superficial Perfusion Oxygen Tension Chip (SPOTchip) measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess change in oxygenation of cutaneous tumors from hyperoxygenation 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.	Up to 1 year

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	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.	Up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare different methods of oxygenation measurement	EPR measurements of pO2 using India ink will be compared to cpO2easurements using SPOTChip.	Up to 1 year

Collaborators and Investigators

• Sponsor: West Virginia University
• Investigators: Principal Investigator: Todd Tenenholz, MD, PhD, West Virginia University Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2018
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: pO2 Measurements, EPR, Carcinoma; India Ink; OxySPOT
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: WVU011118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No