Evaluation of Technetium Tc 99m Tilmanocept Localization, Retention, and Distribution in Primary Cutaneous Kaposi's Sarcoma (KS) and Lymphatic Drainage From KS Lesions by SPECT/CT Imaging.

Navidea Biopharmaceuticals1 site in 1 country5 target enrollmentSeptember 2014

ConditionsKaposi's Sarcoma

InterventionsTc 99m tilmanocept

DrugsTc 99m tilmanocept

Overview

Phase: Phase 2
Intervention: Tc 99m tilmanocept
Conditions: Kaposi's Sarcoma
Sponsor: Navidea Biopharmaceuticals
Enrollment: 5
Locations: 1
Primary Endpoint: Localization
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

October 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Navidea Biopharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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.

Exclusion Criteria

•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.

Arms & Interventions

Tc 99m tilmanocept

Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.

Intervention: Tc 99m tilmanocept

Outcomes

Primary Outcomes

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.