Clinical Trial: An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) Injection in Kaposi Sarcoma (KS)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection in Subjects Diagnosed With Kaposi Sarcoma (KS)

Brief Summary: To determine the safety of escalating doses of Tc 99m tilmanocept in HIV (human immunodeficiency virus) subjects with confirmed KS.

Detailed Summary:

This is a prospective, single-center, open-label, within-subject study of intravenously injected Tc 99m tilmanocept in the localization and detection of non-cutaneous and cutaneous KS tumor(s) in subjects with confirmed KS. Four IV mass doses (µg/mCi) of tilmanocept will be evaluated in cohort groups.

This study is designed to evaluate the safety and tolerability of escalating doses of Tc 99m tilmanocept. Whole body planar as well as 3D SPECT or SPECT/CT imaging to provide greater resolution of areas of Tc 99m tilmanocept localization.

This study is designed to evaluate the use of Tc 99m tilmanocept as an imaging agent in HIV-positive subjects with known KS by evaluating the localization in known and unknown cutaneous and visceral lesions.


Sponsor: Navidea Biopharmaceuticals

Current Primary Outcome: Adverse Drug Reaction [ Time Frame: 5 days after Tc 99m tilmanocept injection ]

Proportion of subjects experiencing a pharmacologic activity or an Adverse Drug Reaction (ADR).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Per Subject Localization [ Time Frame: 5 days after Tc 99m tilmanocept injection ]
    Per subject localization rate of Tc 99m tilmanocept by SPECT imaging
  • Per lesion localization [ Time Frame: 5 days after Tc 99m tilmanocept injection ]
    Per lesion localization rate of Tc 99m tilmanocept by SPECT imaging
  • Localization concordance with physical observations [ Time Frame: 5 days after Tc 99m tilmanocept injection ]
    Concordance of Tc 99m localization with anatomical areas of active KS or other pathology defined by clinical symptomology.
  • Localization Intensity [ Time Frame: 5 days after Tc 99m tilmanocept injection ]
    Localization intensity for each clinically defined focus (as determined by quantitative SPECT gamma counts)
  • Per subject localization [ Time Frame: 5 days after Tc 99m tilmanocept injection ]
    Per subject localization rate of Tc 99m tilmanocept in areas other than cutaneous KS by SPECT and or SPECT/CT imaging
  • Per area localization rate [ Time Frame: 5 days after Tc 99m tilmanocept injection ]
    Per area localization rate of Tc 99m tilmanocept in the most frequently identified areas other than cutaneous KS by SPECT and/or SPECT CT imaging


Original Secondary Outcome: Same as current

Information By: Navidea Biopharmaceuticals

Dates:
Date Received: May 4, 2017
Date Started: July 15, 2017
Date Completion: March 31, 2018
Last Updated: May 16, 2017
Last Verified: May 2017