MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Southern California
University of Toronto
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01649661
First received: July 19, 2012
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Cancer Free Women
Behavioral: questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Epidemiology of MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • breast cancer risk factors and background parenchymal enhancement (BPE). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • relationship between BPE and serum hormone levels at the time of MRI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Blood sample collected at time of MRI for serum hormone analysis Postmenopausal women only


Estimated Enrollment: 420
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649661

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
University of Southern California
University of Toronto
Investigators
Principal Investigator: Janice Sung, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01649661     History of Changes
Other Study ID Numbers: 12-125
Study First Received: July 19, 2012
Last Updated: August 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
MRI
12-125
premenopausal women
postmenopausal women
questionnaire

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014