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

NCT01129622 | Completed Phase 2 Results

• 1 other identifier: CFWH-AI1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Letrozole; Breast MRI; Postmenopausal women

Outcome Measures

Primary Outcomes (1)

• Number of Women With Reduced Breast Parenchymal 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 Outcomes (1)

• Number of Participants Developed Adverse Effects of 12.5 mg of Letrozole

  Three days plus One Week following medication

Study Arms (1)

Letrozole, Breast enhancement, Safety

EXPERIMENTAL

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

Interventions

letrozole DRUG

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.

Also known as: Femara TM Novartis Pharmaceuticals Canada Inc., Dorval, QC

Letrozole, Breast enhancement, Safety

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• History of bilateral mastectomy, osteoporosis or renal impairment.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5T 3H7, Canada

Location

Related Publications (1)

• Mousa NA, Eiada R, Crystal P, Nayot D, Casper RF. The effect of acute aromatase inhibition on breast parenchymal enhancement in magnetic resonance imaging: a prospective pilot clinical trial. Menopause. 2012 Apr;19(4):420-5. doi: 10.1097/gme.0b013e31823772a8.

  PMID: 22258545 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The small sample size is a limitation.

Results Point of Contact

• Title: Robert F Casper
• Organization: Mount Sinai Hospital

casper@lunenfeld.ca

416-972-0777

Study Officials

• Robert F Casper, MD

  Mount Sinai Hopsital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: May 24, 2010
• Study Start: October 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2010
• Last Updated: May 1, 2014
• Results First Posted: May 1, 2014

Record last verified: 2014-04

Locations

CA (1)