Clinical Trial: Evaluation of Tc 99m Tilmanocept Localization in Primary Cutaneous Kaposi's Sarcoma and Lymphatic Drainage by SPECT/CT
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of Technetium Tc 99m Tilmanocept Localization, Retention, and Distribution in Primary Cutaneous Kaposi's Sarcoma (KS) and Lymphatic Drainage From KS Lesions by
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 center, open-label, within-subject study.
Detailed Summary:
Sponsor: Navidea Biopharmaceuticals
Current Primary Outcome: Localization [ Time Frame: Up to 4 days ]
Original Primary Outcome: Marker lesion localization [ Time Frame: Up to 4 days ]
Current Secondary Outcome: Time to Localization [ Time Frame: 1 hour ]
Original Secondary Outcome:
- Time to Localization [ Time Frame: Up to 4 days ]Time to first localization of the marker lesion or lymph node.
- Safety [ Time Frame: Up to 4 days ]Adverse events, clinical laboratory tests, vital signs, and physical examinations.
Information By: Navidea Biopharmaceuticals
Dates:
Date Received: July 24, 2014
Date Started: September 2014
Date Completion:
Last Updated: August 3, 2016
Last Verified: August 2016