At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 40 enrolled

Drug / intervention

Lymphoseek +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02287675

NCT02287675Phase 4Completed

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A Randomized, Double-Blinded Trial Comparing Lymphoseek and 99mTc-Sulfur Colloid With Regard to Pre-op Imaging and Imaging Drug Kinetics and Intra-op Lymphatic Mapping and Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer

Kettering Health Network·interventional·Posted Nov 11, 2014·Updated Jul 28, 2020

In Brief

A Phase 4 clinical trial evaluating Lymphoseek and Sulfur Colloid for Breast Cancer. Completed, enrolled 40 participants across 1 site.

Detailed Summary

To compare the kinetics and efficacy of two functionally different diagnostic agents, Lymphoseek (CD206 receptor targeted) and 99mTc-Sulfur Colloid (SC) (Sulfur Colloid non-specific mapping agent) in intraoperative lymphatic mapping (ILM) and Sentinel Lymph Node Biopsy (SLNB).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Cancer

CountriesUnited States

Collaborators--

Timeline

Phase 4CompletedFinished

201520162017201820192020202120222023202420252026

First PostedNov 2014

Enrollment StartJan 2015

Primary CompletionJan 2017

Study CompletionAug 2017

TodayJul 2026

First PostedNov 11, 2014

Enrollment StartJan 19, 2015

Primary CompletionJan 23, 2017

Study CompletionAug 31, 2017

TodayJul 2, 2026

Enrollment to primary: 2.0 yearsPosted 11.6 years ago

Interventions

Lymphoseekdrug

Subjects will receive a single intradermal injection of Lymphoseek followed by SPECT imaging conducted in two phases: initial sequential planar imaging at 30 to 60 second intervals for the first 60 minutes and repeated at 90 minutes and 120 minutes, as indicated, for identification of the SLN followed by SPECT/CT for higher resolution imaging in transaxial, coronal, and sagittal planes. Subjects will then proceed to surgery for lymphatic mapping. Lymphoseek positivity will be based upon radioactivity counts derived from the application of the handheld gamma probe ex vivo. Tumor resection or mastectomy will be performed according to standard procedures.

Sulfur Colloiddrug

Subjects will receive a single intradermal injection of 99mTc-SC followed by SPECT imaging conducted in two phases: initial sequential planar imaging at 30 to 60 second intervals for the first 60 minutes and repeated at 90 minutes and 120 minutes, as indicated, for identification of the SLN followed by SPECT/CT for higher resolution imaging in transaxial, coronal, and sagittal planes. Subjects will then proceed to surgery for lymphatic mapping. 99mTc-SC positivity will be based upon radioactivity counts derived from the application of the handheld gamma probe ex vivo. Tumor resection or mastectomy will be performed according to standard procedures.