Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT03321903
Eligibility Criteria:
Inclusion Criteria:
1. Subject must be capable of giving informed consent or has an acceptable surrogate capable of giving consent on behalf of the subject.
2. 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.
1. 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 Criteria:
1. Previous adverse reaction to a charcoal product e.g., a local hypersensitive response from a black tattoo or from ingestion of activated charcoal
2. Previous adverse reaction to the suspending agent
3. Subject has a pacemaker that is not known to be MRI compatible
4. Subject has a non-removable implant or device with metal that is not known to be MRI compatible
5. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03321903
Study Brief:
Protocol Section:
NCT03321903