MRI Parenchymal Enhancement: A New Marker of Breast Cancer Risk

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01649661

Enrollment

437

Registered

2012-07-25

Start date

2012-07-31

Completion date

2023-01-25

Last updated

2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Free Women

Keywords

MRI, 12-125, premenopausal women, postmenopausal women, questionnaire

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.

Interventions

BEHAVIORALquestionnaire

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026