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 ]

Count of subjects with a localization by Tc 99m tilmanocept by imaging. Localization is based on the use of SPECT imaging and defined as the accumulation of radioactivity at intensity greater than background.


Original Primary Outcome: Marker lesion localization [ Time Frame: Up to 4 days ]

Count and percentage of subjects with a localized marker lesion by Tc 99m tilmanocept by imaging.


Current Secondary Outcome: Time to Localization [ Time Frame: 1 hour ]

Number of Participants with Localization at One 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