MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk

NCT ID: NCT01649661

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

437 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2023-01-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Free Women

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

questionnaire

Intervention Type BEHAVIORAL

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.

questionnaire

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

questionnaire

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Janice Sung, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-125

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.