Evaluation of Tc 99m Tilmanocept Localization in Primary Cutaneous Kaposi's Sarcoma and Lymphatic Drainage by SPECT/CT

Completed · Phase 2

Conditions studied: Kaposi's Sarcoma

In brief

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 center, open-label, within-subject study.

Key facts

Study ID

NCT02201420

Run by

Navidea Biopharmaceuticals

People needed

5

Starts

2014-09-01

Expected to finish

2015-10-01

Last updated by the study team

2016-09-27

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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