Clinical trial NCT04877912: Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening
Official title: Development and Testing of an Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening - A Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: MRI Screening
Breast cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 200
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have had a mammographically and/or sonographically identified finding that will require image guided biopsy.

Women between ages 40-74 with dense breasts having a mammogram

Women who have been identified as having an average or intermediate risk of breast cancer (defined as 10-20% lifetime risk based on a clinical risk model)

Brief summary: The purpose of this study is to test an innovative MRI breast cancer screening method in women with mammographically dense breasts as well as other women with moderately increased cancer risk. MRI, combined with other methods of risk assessment, has potential to significantly improve sensitivity to cancer in dense breasts and detect cancer in all cases at a much earlier stage, with far fewer interval cancers than mammography. Previous tests of MRI sensitivity show that this screening could significantly increase the likelihood of detecting invasive cancers resulting in decreased mortality from breast cancer.

Suspicious lesions will be defined by the clinical interpretation of the breast MRI images performed by the attending breast radiologists. Based on the radiologist determination that the MRI findings are suspicious (these findings include masses, non-mass enhancement and foci), suspicious lesions will be assigned a Bi-Rads code specifying whether additional work up or biopsy is necessary. These are Bi-Rads codes 0, 4 and 5. False positive diagnosis should be minimized as all attending physicians reading breast MRI at this institution are fellowship trained in breast imaging.


Eligibility criteria: Inclusion Criteria:

* Women that have had a mammographically and/or sonographically identified finding that will require image guided biopsy
* Women between ages 40-74 with dense breasts having a mammogram
* Women identified as having an average or intermediate risk of breast cancer (defined as 10- 20% lifetime risk based on a clinical risk model).

Exclusion Criteria:

* Women with metallic implants
* Women that are claustrophobic
* Women that have a fear of needles or contrast
* Women that have had an allergic reaction to contrast in the past
* Women that are pregnant
* Women who are demonstrated to be at risk for an allergic reaction or nephrogenic systemic fibrosis (NSF)

Primary outcomes:
measure: True Positive
timeFrame: 1 day
Secondary outcomes:
measure: True Negative
timeFrame: 1 day
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Mitchell Hospital
state: Illinois
Study officials:
References: