Status:
TERMINATED
EPR Tumor Oximetry With CE India Ink
Lead Sponsor:
Philip Schaner
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neoplasms, Malignant
Breast Neoplasm
Eligibility:
All Genders
18+ years
Brief Summary
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 che...
Detailed Description
The study design uses consecutively enrolled patients. Patients can participate as long as they are willing, fit the criteria for being assigned to a cohort, and the India ink spot remains measurable ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 30 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 27 2019
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03321903
Start Date
August 30 2017
End Date
October 27 2019
Last Update
December 19 2019
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766