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

Primary Purpose

Kaposi's Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tc 99m tilmanocept
Sponsored by
Navidea Biopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kaposi's Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Francisco General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tc 99m tilmanocept

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Localization
Number of Participants with Localization at One Hour

Full Information

First Posted
July 24, 2014
Last Updated
August 3, 2016
Sponsor
Navidea Biopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02201420
Brief Title
Evaluation of Tc 99m Tilmanocept Localization in Primary Cutaneous Kaposi's Sarcoma and Lymphatic Drainage by SPECT/CT
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Navidea Biopharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kaposi's Sarcoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tc 99m tilmanocept
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tc 99m tilmanocept
Other Intervention Name(s)
Lymphoseek
Primary Outcome Measure Information:
Title
Localization
Description
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.
Time Frame
Up to 4 days
Secondary Outcome Measure Information:
Title
Time to Localization
Description
Number of Participants with Localization at One Hour
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie C Abbruzzese, MS, RD, CCRA
Organizational Affiliation
Navidea Biopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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