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

NCT02201420 | Completed Phase 2 Results

• 1 other identifier: NAV3-12
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Localization

  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.

  Up to 4 days

Secondary Outcomes (1)

• Time to Localization

  1 hour

Study Arms (1)

Tc 99m tilmanocept

EXPERIMENTAL

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.

Drug: Tc 99m tilmanocept

Interventions

Tc 99m tilmanocept DRUG

Also known as: Lymphoseek

Tc 99m tilmanocept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 2.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navidea Biopharmaceuticals: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Sarcoma, Kaposi

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Results Point of Contact

• Title: Dr. Frederick O. Cope, Chief Scientific Officer
• Organization: Navidea Biopharmaceuticals, Inc.

fcope@navidea.com

614-793-7500

Study Officials

• Bonnie C Abbruzzese, MS, RD, CCRA

  Navidea Biopharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 28, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 27, 2016
• Results First Posted: September 27, 2016

Record last verified: 2016-08

Locations

US (1)