Phase 2
N=5
Evaluation of Tc 99m Tilmanocept Localization in Primary Cutaneous Kaposi's Sarcoma and Lymphatic Drainage by SPECT/CT
Kaposi's Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT02201420 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Localization — 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tc 99m tilmanocept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Navidea Biopharmaceuticals
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Localization |
5 | — |
| SECONDARY Time to Localization |
5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02201420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.