Status:
COMPLETED
Evaluation of Tc 99m Tilmanocept Localization in Primary Cutaneous Kaposi's Sarcoma and Lymphatic Drainage by SPECT/CT
Lead Sponsor:
Navidea Biopharmaceuticals
Conditions:
Kaposi's Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study (NAV3-12) is to determine the dissemination and localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with confirmed cutaneous KS. This is a single cen...
Eligibility Criteria
Inclusion
- The subject has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before the initiation of any study-related procedures.
- The subject is at least 18 years of age at the time of consent.
- The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 2.
- The subject has a KS stage of T(0), I(0), S(0).
- The subject has a marker lesion with a confirmed diagnosis of KS (CD 206-expressing cutaneous KS) via punch biopsy. The location of the marker KS lesion will be limited to locations on the extremities: from the shoulder to the metacarpal region or from the groin to the metatarsal region.
- The subject has a marker KS lesion that is ≥ 1cm in diameter.
Exclusion
- The subject is pregnant or lactating.
- The subject has had prior chemotherapy, immunotherapy, or radiation therapy to the local KS site or regional lymphatic system within one year of enrollment.
- The subject has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the marker KS lesion.
- The subject has known sensitivity to dextran.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02201420
Start Date
September 1 2014
End Date
October 1 2015
Last Update
September 27 2016
Active Locations (1)
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1
San Francisco General Hospital
San Francisco, California, United States, 94143