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



Status:Completed
Conditions:Skin Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/15/2016
Start Date:September 2014
End Date:October 2015

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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.

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.


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.
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