EPR Tumor Oximetry With CE India Ink

Stopped early

Conditions studied: Neoplasms, Malignant, Breast Neoplasm, Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Melanoma, Skin Neoplasm, Head and Neck Neoplasms

In brief

It has been well established that malignant tumors tend to have low levels of oxygen and that tumors with very low levels of oxygen are more resistant to radiotherapy and other treatments, such as chemotherapy and immunotherapy. Previous attempts to improve response to therapy by increasing the oxygen level of tissues have had disappointing results and collectively have not led to changing clinical practice. Without a method to measure oxygen levels in tumors or the ability to monitor over time whether tumors are responding to methods to increase oxygen during therapy, clinician's reluctance to use oxygen therapy in usual practice is not surprising. The hypothesis underlying this research is that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, including combined therapy, and to minimize normal tissue side effects or complications. Because studies have found that tumors vary both in their initial levels of oxygen and exhibit changing patterns during growth and treatment, we propose to monitor oxygen levels in tumors and their responsiveness to hyperoxygenation procedures. Such knowledge about oxygen levels in tumor tissues and their responsiveness to hyper-oxygenation could potentially be used to select subjects for particular types of treatment, or otherwise to adjust routine care for patients known to have hypoxic but unresponsive tumors in order to improve their outcomes. The overall objectives of this study are to establish the clinical feasibility and efficacy of using in vivo electron paramagnetic resonance (EPR) oximetry-a technique related to magnetic resonance imaging (MRI)-to obtain direct and repeated measurements of clinically useful information about tumor tissue oxygenation in specific groups of subjects with the same types of tumors, and to establish the clinical feasibility and efficacy of using inhalation of enriched oxygen to gain additional clinically useful information about responsiveness of tumors to hyper-oxygenation. Two devices are used: a paramagnetic charcoal suspension (Carlo Erba India ink) and in vivo EPR oximetry to assess oxygen levels. The ink is injected and becomes permanent in the tissue at the site of injection unless removed; thereafter, the in vivo oximetry measurements are noninvasive and can be repeated indefinitely.

Key facts

Study ID: NCT03321903
Run by: Philip Schaner
People needed: 3
Starts: 2017-08-30
Expected to finish: 2019-10-27
Last updated by the study team: 2019-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject must be capable of giving informed consent or has an acceptable surrogate capable of giving consent on behalf of the subject.
Subject has an eligible tumor that is within 5 mm of the surface (either skin or mucosa) or has had a tumor removed with a tumor bed that is within 5 mm of the surface.
Eligible tumors types:
Intraoral tumors: squamous cell carcinoma (SCC), melanoma;
Primary cutaneous tumors (including, but not limited to): SCC, basal cell carcinoma (BCC,) melanoma;
Breast malignancies post surgery;
Other tumors: any tumor within 5 mm of the surface and with planned radiation therapy.

You may not qualify if…

Previous adverse reaction to a charcoal product e.g., a local hypersensitive response from a black tattoo or from ingestion of activated charcoal
Previous adverse reaction to the suspending agent
Subject has a pacemaker that is not known to be MRI compatible
Subject has a non-removable implant or device with metal that is not known to be MRI compatible
Subject is pregnant or has a likelihood for becoming pregnant during the basic study timeframe.
Note: There is no known harm to the woman or her fetus from participating; this is precautionary only.

Where it is running

Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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