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:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT03157167
Eligibility Criteria:
Inclusion Criteria:
1. The subject has provided written informed consent with HIPAA authorization before the initiation of any study-related procedures.
2. The subject is at least 18 years of age at the time of consent.
3. The subject is HIV positive.
4. The subject has a biopsy-confirmed diagnosis of KS and is classified into one of the categories below:
1. Confirmed cutaneous KS/oral lesions without edema.
2. Confirmed cutaneous KS/oral lesions with edema.
3. Confirmed cutaneous KS/oral lesions with or without edema and suspected non-cutaneous KS due to clinical symptomology or confirmed non-cutaneous KS lesion(s).
Exclusion Criteria:
1. The subject is pregnant or lactating.
2. The subject has received chemotherapy or radiation therapy to KS sites within six weeks of enrollment.
3. The subject has known sensitivity to dextran.
4. The subject has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration on Day 1.
5. The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept on Day 1.
6. Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03157167
Study Brief:
Protocol Section:
NCT03157167