Effect of Aromatase Inhibitors on Breast Magnetic Resonance Imaging (MRI) (RFCLET2)

April 1, 2014 updated by: Robert Casper, Mount Sinai Hospital, Canada

Phase II Study of the Effect of Acute Aromatase Inhibition on Breast MRI Postmenopausal Women

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 3H7
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women are eligible to participate if they are 40 years or older and have been menopausal (had no menstrual bleeding during the past 12 months)

Exclusion Criteria:

  • History of bilateral mastectomy, osteoporosis or renal impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 .
Drug: letrozole
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 Names:
  • Femara TM Novartis Pharmaceuticals Canada Inc., Dorval, QC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
One month MRI study after letrozole compared to baseline MRI study, both with gadolinium enhancement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole
Time Frame: Three days plus One Week following medication
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.
Three days plus One Week following medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Sinai Hospital, Canada

Investigators

  • Principal Investigator: Robert F Casper, MD, Mount Sinai Hopsital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

May 21, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (Estimate)

May 24, 2010

Study Record Updates

Last Update Posted (Estimate)

May 1, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFWH-AI1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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