MRI + Mammography for Breast Cancer Screening

Recruiting in Palo Alto (17 mi)

+67 other locations

Overseen byChristopher Comstock

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: ECOG-ACRIN Cancer Research Group

No Placebo Group

Trial Summary

What is the purpose of this trial?This randomized phase II trial studies how well abbreviated breast magnetic resonance imaging (MRI) and digital tomosynthesis mammography work in detecting cancer in women with dense breasts. Abbreviated breast MRI is a low cost procedure in which radio waves and a powerful magnet linked to a computer and used to create detailed pictures of the breast in less than 10 minutes. These pictures can show the difference between normal and diseased tissue. Digital tomosynthesis mammography is a procedure that uses multiple x-rays pictures of each breast to produce a 3-dimensional rendering of the entire breast. Combined screening with abbreviated breast MRI and digital tomosynthesis mammography may be a better method to screen women with dense breasts.

Eligibility Criteria

This trial is for women with dense breasts who are due for routine screening, not pregnant or breastfeeding, and have no history of breast cancer or high-risk lesions. They mustn't be taking breast cancer prevention drugs, haven't had a breast MRI before, and can undergo an MRI with contrast. Women at high risk for breast cancer or those with certain health conditions like severe allergies to gadolinium or renal impairment are excluded.

Inclusion Criteria

Patents must be scheduled for routine screening DBT

Patient must be asymptomatic for breast disease and undergoing routine screening

Women must not be pregnant or breast-feeding; all females of childbearing potential who are uncertain if they could be pregnant or may be pregnant or as per local site standard of practice in women undergoing DBT and MRI must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

+10 more

Exclusion Criteria

No contraindication to intravenous contrast administration

No women who have breast prosthetic implants (silicone or saline)

You do not have a history of sickle cell disease.

+6 more

Participant Groups

The study is testing if abbreviated breast MRI—a quick, detailed imaging technique—and digital tomosynthesis mammography—a 3D X-ray of the breast—are effective in detecting cancer in women with dense breasts when used together compared to current standard screening methods.

2Treatment groups

Experimental Treatment

Group I: Arm B (AB-MR, DBT)Experimental Treatment4 Interventions

Participants undergo AB-MR for under 10 minutes followed by DBT on the same day or within 24 hours at baseline and then after 1year.

Group II: Arm A (DBT, AB-MR)Experimental Treatment4 Interventions

Participants undergo DBT followed by AB-MR for under 10 minutes on the same day or within 24 hours at baseline and then after 1 year.