Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer

PHASE4CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 19, 2015

Primary Completion Date

January 23, 2017

Study Completion Date

August 31, 2017

Conditions
Breast Cancer
Interventions
DRUG

Lymphoseek

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.

DRUG

Sulfur Colloid

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.

Trial Locations (1)

45429

Kettering Medical Center, Kettering

All Listed Sponsors
lead

Kettering Health Network

OTHER

NCT02287675 - Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer | Biotech Hunter | Biotech Hunter