MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk

Completed

• Conditions: Cancer Free Women
• Interventions: Behavioral: questionnaire

• Registration Number: NCT01649661
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-25
• Status Verified: 2023-01
• Primary Completion: 2023-01-25
• Study Completion: 2023-01-25
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 437

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
postmenopausal women	questionnaire	Only women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes.
premenopausal women	questionnaire	Only women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes.

Primary Outcome Measures

Name	Time	Method
breast cancer risk factors and background parenchymal enhancement (BPE).	1 year	A comparison of the distribution of breast cancer risk factors in women with low and high levels of BPE. The relationship between risk factors and categories of BPE (minimal/mild/moderate/marked) will be determined using ordinal logistic regression.

Secondary Outcome Measures

Name	Time	Method
relationship between BPE and serum hormone levels at the time of MRI	1 year	Determine the relationship between serum hormone levels (testosterone, estradiol (E2), estrone (E1), androstenedione (A4) and sex hormone binding globulin (SHBG)) at the time of MRI and degree of BPE in healthy high-risk postmenopausal women. The association between circulating serum hormone levels and BPE will be determined using linear regression.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States