Clinical Trial · NCT02201420

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

Overview

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.

Sponsor

Avid Radiopharmaceuticals

Phase

Phase 2

Contacts

Bonnie C Abbruzzese, MS, RD, CCRA (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT02201420

Drug / Compound

tilmanocept

Isotope(s):
Target(s):
  • Mannose Receptor (CD206/MRC1)
Ligand Class: Small Molecules
Chelator: DTPA

Eligibility

Inclusion

  • 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 KS stage of T(0), I(0), S(0).
  • The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 2.
  • The subject has a marker KS lesion that is ≥ 1cm in diameter.

Exclusion

  • The subject has known sensitivity to dextran.
  • 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.