MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk

January 25, 2023 updated by: Memorial Sloan Kettering Cancer Center

Epidemiology of MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

437

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

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The proposed study will involve cancer-free women who are undergoing breast MRI screening at MSKCC.

Description

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 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

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
premenopausal women
Only women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes.
Behavioral: questionnaire
Other Names:
  • The study questionnaire is a 15-20 minute survey at or shortly after the time of MRI consisting of 27
  • questions in 7 domains:background information (e.g., date of birth, country of birth, race/ethnicity), medical
  • history, family history of cancer, reproductive history, use of hormonal medications, alcohol and
  • smoking, contact information/comments.
postmenopausal women
Only women already scheduled for a breast MRI will be included in the study, no additional MRIs will be scheduled for study purposes.
Behavioral: questionnaire
Other Names:
  • The study questionnaire is a 15-20 minute survey at or shortly after the time of MRI consisting of 27
  • questions in 7 domains:background information (e.g., date of birth, country of birth, race/ethnicity), medical
  • history, family history of cancer, reproductive history, use of hormonal medications, alcohol and
  • smoking, contact information/comments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breast cancer risk factors and background parenchymal enhancement (BPE).
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relationship between BPE and serum hormone levels at the time of MRI
Time Frame: 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.
1 year

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)
University of Southern California
University of Toronto

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.

Helpful Links

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

July 1, 2012

Primary Completion (Actual)

January 25, 2023

Study Completion (Actual)

January 25, 2023

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

July 24, 2012

First Posted (Estimate)

July 25, 2012

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12-125

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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