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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Mount Sinai Hospital, Canada.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01129622
First received: May 21, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Postmenopause
 Drug: letrozole
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
Drug Information available for: Letrozole
U.S. FDA Resources

Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Breast parenchymal background enhancement [ Time Frame: Three days ] [ Designated as safety issue: No ]
    Objective image analysis of background enhancement of benign breast parenchyma Subjective evaluation of diagnostic confidence by radiologists


Secondary Outcome Measures:
  • Adverse Effects of 12.5 mg of Letrozole [ Time Frame: Three days plus One Week following medication ] [ Designated as safety issue: Yes ]
    Short term hypoestrogenic side effects or other adverse effects during the intake of the medication or in the following week


Enrollment: 16
Study Start Date: October 2008
Estimated Study Completion Date: September 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole, Breast enhancement, safety
Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
 Drug: letrozole
Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
Other Name: Femara TM Novartis Pharmaceuticals Canada Inc., Dorval, QC

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women are eligible to participate if they RE 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129622

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5T 3H7
Sponsors and Collaborators
Mount Sinai Hospital, Canada
  More Information

No publications provided by Mount Sinai Hospital, Canada

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Robert F. Casper, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01129622     History of Changes
Other Study ID Numbers: CFWH-AI1
Study First Received: May 21, 2010
Last Updated: May 21, 2010
Health Authority: Canada: Health Canada

Keywords provided by Mount Sinai Hospital, Canada:
letrozole
breast MRI
Postmenopausal women

Additional relevant MeSH terms:
Letrozole
Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013