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Completed

NCT Number: NCT02201420

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Francisco General Hospital

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

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.

Treatment and study plan

Tc 99m tilmanocept

Drug

Other names: Lymphoseek

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to Localization

    Time frame: 1 hour

    Number of Participants with Localization at One Hour

Sponsors and collaborators

Lead sponsor

Navidea Biopharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 28, 2014
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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