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

Kaposi's Sarcoma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201420
• Other study ID #: NAV3-12
• Status: Completed
• Phase: Phase 2
• First received: July 24, 2014
• Last updated: June 13, 2016
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: June 2016
• Source: Navidea Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Kaposi's Sarcoma
• Sarcoma
• Sarcoma, Kaposi
• Skin Neoplasms

Intervention

Drug:
• Tc 99m tilmanocept

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Navidea Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Localization	Count and percentage of subjects with a localization by Tc 99m tilmanocept by imaging.	Up to 4 days	No
Secondary	Time to localization	Time to first localization by Tc 99m tilmanocept.	Up to 4 days	No
Secondary	Safety	Adverse events	Up to 4 days	Yes