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

Phase 2

Completed

• Conditions: Kaposi's Sarcoma
• Interventions: Drug: Tc 99m tilmanocept

• Registration Number: NCT02201420
• Lead Sponsor: Navidea Biopharmaceuticals

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-28
• Study Start: 2014-09
• Primary Completion: 2015-03
• Study Completion: 2015-10
• Results First Submitted: 2016-06-23
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-03
• Last Update Submitted: 2016-08-03
• Results First Posted: 2016-09-27
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. The subject has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before the initiation of any study-related procedures.
2. The subject is at least 18 years of age at the time of consent.
3. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 2.
4. The subject has a KS stage of T(0), I(0), S(0).
5. 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.
6. The subject has a marker KS lesion that is ≥ 1cm in diameter.

Exclusion Criteria

1. The subject is pregnant or lactating.
2. The subject has had prior chemotherapy, immunotherapy, or radiation therapy to the local KS site or regional lymphatic system within one year of enrollment.
3. The subject has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the marker KS lesion.
4. The subject has known sensitivity to dextran.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tc 99m tilmanocept	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.

Primary Outcome Measures

Name	Time	Method
Localization	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.

Secondary Outcome Measures

Name	Time	Method
Time to Localization	1 hour	Number of Participants with Localization at One Hour

Trial Locations

Locations (1)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States