TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer

NARecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

December 12, 2018

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Breast Cancer
Interventions
DEVICE

TMEM-MRI

TMEM MRI INFORMATION: Unilateral breast MRI will be obtained on a 3.0T whole body MRI scanner with a dedicated breast radiofrequency coil. The patient will be scanned in the prone position with an in-dwelling IV catheter for a single dose contrast agent injection.

PROCEDURE

FNA

FNA: The patients who are recruited prior to biopsy (Cohort A) will have had TMEM-MRI performed prior to biopsy. They will then present to radiology for ultrasound-guided core biopsy of the breast mass. FNA will be performed during this procedure. The FNA will be performed after local anesthetic is administered but prior to insertion of the core biopsy needle. FNA will be performed by the radiologist under direct sonographic visualization of the mass. Five passes will be obtained with a 25 gauge needle. The FNA material will be expelled into 1.5 ml Eppendorf tube containing phosphate buffered saline with EDTA.

Trial Locations (1)

10461

RECRUITING

Montefiore Medical Center, The Bronx

All Listed Sponsors
lead

Montefiore Medical Center

OTHER