MRI + Mammography for Breast Cancer Screening

Recruiting at 67 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: ECOG-ACRIN Cancer Research Group

Must not be taking: Chemoprevention

Disqualifiers: Pregnancy, Breast cancer, High-risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

1516 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be taking medication for breast cancer prevention.

What data supports the effectiveness of the treatment Abbreviated Breast MRI, Digital Tomosynthesis Mammography, Digital Breast Tomosynthesis, DBT, 3D Mammography for breast cancer screening?

Research shows that combining digital breast tomosynthesis (DBT) and magnetic resonance imaging (MRI) with mammography improves the ability to detect breast cancer compared to using mammography alone. This combination is particularly effective in evaluating the extent of disease and identifying suspicious lesions in women with breast cancer. ^{1 2 3 4 5}

Is MRI plus mammography safe for breast cancer screening?

The studies reviewed focus on the diagnostic performance of MRI and digital breast tomosynthesis (DBT) combined with mammography, but they do not specifically address safety concerns. Generally, MRI and mammography are considered safe imaging techniques, with MRI using magnetic fields and radio waves, and mammography involving low-dose X-rays. ^{4 5 6 7 8}

How is the treatment of MRI plus mammography for breast cancer screening different from other treatments?

This treatment combines MRI (a detailed imaging technique) with digital tomosynthesis mammography (3D mammography) to improve the detection of breast cancer, especially in women with dense breast tissue or higher risk, offering a more comprehensive screening compared to traditional mammography alone. ^{2 3 4 6 9}

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.

Research Team

Christopher Comstock

Principal Investigator

ECOG-ACRIN Cancer Research Group

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)

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants undergo DBT and AB-MR on the same day or within 24 hours

1 day

1 visit (in-person)

1-Year Follow-up Testing

Participants undergo follow-up DBT and AB-MR after 1 year

1 day

1 visit (in-person)

Long-term Follow-up

Participants are monitored every 6 months for 3 years after the study completion

3 years

6 visits (in-person)

Treatment Details

Interventions

• Abbreviated Breast MRI
• Digital Tomosynthesis Mammography

Trial Overview 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.

Participant Groups

Group I: Arm B (AB-MR, DBT) Experimental Treatment 4 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 Treatment 4 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.

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Assessment of disease extent on contrast-enhanced MRI in breast cancer detected at digital breast tomosynthesis versus digital mammography alone. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Comparison of the diagnostic performance of digital breast tomosynthesis and magnetic resonance imaging added to digital mammography in women with known breast cancers. [2020]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Digital Breast Tomosynthesis versus MRI as an Adjunct to Full-Field Digital Mammography for Preoperative Evaluation of Breast Cancer according to Mammographic Density. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Digital breast tomosynthesis plus mammography, magnetic resonance imaging plus mammography and mammography alone: A comparison of diagnostic performance in symptomatic women. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Assessment of MRI-detected lesions on screening tomosynthesis in patients with newly diagnosed breast cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Performance of Screening Breast MRI After Negative Full-Field Digital Mammography Versus After Negative Digital Breast Tomosynthesis in Women at Higher Than Average Risk for Breast Cancer. [2022]

7. Turkey pubmed.ncbi.nlm.nih.gov

Changing Paradigms in Breast Cancer Screening: Abbreviated Breast MRI. [2020]

8. Ireland pubmed.ncbi.nlm.nih.gov

Replacing single-view mediolateral oblique (MLO) digital mammography (DM) with synthesized mammography (SM) with digital breast tomosynthesis (DBT) images: Comparison of the diagnostic performance and radiation dose with two-view DM with or without MLO-DBT. [2019]

9. China pubmed.ncbi.nlm.nih.gov

[Diagnosis of breast diseases by mammography in combination with MRI]. [2016]