Effect of Aromatase Inhibitors on Breast Magnetic Resonance Imaging (MRI) (RFCLET2)
This study is a primary investigation to determine the usefulness and safety of a short course of a relatively high dose of letrozole (a medication used to decrease the female hormone estrogen which is produced locally inside the breast after menopause) in improving the performance of of breast MRI (Magnetic Resonance Imaging). The inhibition of estrogen in the breast by letrozole might help better identifying of suspicious areas in the breast and could assist radiologists in distinguishing between benign breast areas and cancer tissue. This might help reducing the rate of call backs and unnecessary biopsies for patients. We expect to enroll 20 healthy postmenopausal women in this study.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Phase II Study of the Effect of Acute Aromatase Inhibition on Breast MRI Postmenopausal Women|
- Number of Women With Reduced Breast Parenchymal Enhancement [ Time Frame: One month MRI study after letrozole compared to baseline MRI study, both with gadolinium enhancement ] [ Designated as safety issue: No ]Image analysis was done using the e-film workstation. A region of interest was selected in all images. The signal intensity of enhancement was recorded and the relative enhancement (percentage of increase in signal intensity) was calculated as (SIc − SI)/SI × 100, where SI and SIc are the precontrast and the postcontrast signal intensities, respectively. Relative enhancement was compared at the baseline MRI study and the after one month MRI study for all participants.
- Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole [ Time Frame: Three days plus One Week following medication ] [ Designated as safety issue: Yes ]The number of participants who developed short term hypoestrogenic side effects or other adverse effects of letrozole during the intake of the medication or in the following week.
|Study Start Date:||October 2008|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: Letrozole, Breast enhancement, Safety
Single arm of healthy postmenopausal women who received baseline diagnostic MRI will receive letrozole of 12.5 mg/day orally for three successive days. A second post treatment breast MRI is done right after receiving the three days of letrozole treatment and within one month after the first MRI .
Letrozole (12.5 mg/day ) which is higher than the dose routinely used for therapeutic indications is given for a brief duration (3 successive days) aiming to promote acute aromatase inhibition suitable for pre-diagnostic regimens.
Other Name: Femara TM Novartis Pharmaceuticals Canada Inc., Dorval, QC
A breast MRI will be performed in the standard way for diagnosis and to serve as a baseline. A second MRI will be performed within a month and following administration of letrozole 12.5 mg daily for three days to reduce breast estrogen levels and in anticipation of lowering breast gadolinium dye uptake.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129622
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5T 3H7|
|Principal Investigator:||Robert F Casper, MD||Mount Sinai Hopsital|