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

NCT ID: NCT02201420

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-10-31

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.

Conditions

Kaposi's Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tc 99m tilmanocept

Intervention Type: DRUG

Interventions

Tc 99m tilmanocept

Intervention Type: DRUG

Other Intervention Names

Lymphoseek

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Navidea Biopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bonnie C Abbruzzese, MS, RD, CCRA

Role: STUDY_DIRECTOR

Navidea Biopharmaceuticals

Locations

San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Other Identifiers

NAV3-12

Identifier Type: -

Identifier Source: org_study_id