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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02201420
Recruitment Status : Completed
First Posted : July 28, 2014
Results First Posted : September 27, 2016
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Kaposi's Sarcoma Drug: Tc 99m tilmanocept Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Study Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : October 2015


Arm Intervention/treatment
Experimental: 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.
Drug: Tc 99m tilmanocept
Other Name: Lymphoseek




Primary Outcome Measures :
  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 Outcome Measures :
  1. Time to Localization [ Time Frame: 1 hour ]
    Number of Participants with Localization at One Hour



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201420


Locations
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United States, California
San Francisco General Hospital
San Francisco, California, United States, 94143
Sponsors and Collaborators
Navidea Biopharmaceuticals
Investigators
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Study Director: Bonnie C Abbruzzese, MS, RD, CCRA Navidea Biopharmaceuticals

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Responsible Party: Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT02201420    
Other Study ID Numbers: NAV3-12
First Posted: July 28, 2014    Key Record Dates
Results First Posted: September 27, 2016
Last Update Posted: September 27, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Sarcoma, Kaposi
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue
Dextrans
Technetium Tc 99m Pentetate
Anticoagulants
Plasma Substitutes
Blood Substitutes
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals