Overview

This trial is active, not recruiting.

Condition cancer free women
Treatment questionnaire
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date July 2012
End date July 2017
Trial size 420 participants
Trial identifier NCT01649661, 12-125

Summary

The purpose of this study is to learn about how a woman's health history influences what a normal breast looks like on an MRI. The investigators also want to learn about how the amount of different natural hormones a woman has affects how the breast looks on an MRI. The investigator's hope is that this will help to find women at a high-risk of breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-crossover
Time perspective prospective
Arm
Only women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes.
questionnaire The study questionnaire is a 15-20 minute survey at or shortly after the time of MRI consisting of 27
Only women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes.
questionnaire The study questionnaire is a 15-20 minute survey at or shortly after the time of MRI consisting of 27

Primary Outcomes

Measure
breast cancer risk factors and background parenchymal enhancement (BPE).
time frame: 1 year

Secondary Outcomes

Measure
relationship between BPE and serum hormone levels at the time of MRI
time frame: 1 year

Eligibility Criteria

Female participants at least 21 years old.

Inclusion Criteria: - age 21 years or older - be a cancer-free pre- or postmenopausal woman - have no prior personal history of any cancer (including DCIS, excluding nonmelanoma skin-cancer) - able to speak and read English because the questionnaire is only available in English - able to provide informed consent Exclusion Criteria: - are pregnant at the time of MRI - have a prior personal history of any cancer (including DCIS, excluding nonmelanoma skin cancer)

Additional Information

Official title Epidemiology of MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk
Principal investigator Janice Sung, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.