MRI + Mammography for Breast Cancer Screening

Not currently recruiting at 70 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how well two screening methods—abbreviated breast MRI and digital tomosynthesis mammography (also known as Digital Breast Tomosynthesis or 3D Mammography)—detect breast cancer in women with dense breasts. The trial will assess whether combining these methods yields better results than using just one. Women with dense breast tissue who are not experiencing symptoms or undergoing other breast cancer treatments qualify as good candidates for this study. Participants will undergo both screening methods either on the same day or within 24 hours, both at the start and after one year. As an unphased study, this trial offers participants the chance to contribute to important research that could enhance breast cancer detection methods.

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 prior data suggests that this screening method is safe for women with dense breasts?

Research has shown that abbreviated breast MRI is generally safe and well-tolerated. It accurately and quickly detects breast cancer, with no major safety concerns reported. This method uses radio waves and magnets to create detailed images, without any radiation.

Studies indicate that digital tomosynthesis mammography is also safe and effective. It uses X-rays to create 3D images of the breast, which can help find cancer more accurately, especially in dense breast tissue. Reports suggest it has fewer side effects and requires fewer follow-up tests than traditional mammography.

Both methods are designed for regular use and have proven effective in detecting breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines Abbreviated Breast MRI (AB-MR) and Digital Tomosynthesis Mammography (DBT) for breast cancer screening, potentially enhancing early detection. Unlike traditional mammography, DBT provides a 3D image of the breast, improving accuracy and reducing false positives. Meanwhile, AB-MR is a quicker version of the standard MRI, taking less than 10 minutes, which makes it more accessible and less time-consuming for patients. By exploring the effectiveness of using these techniques together, researchers hope to improve screening accuracy and provide a more comprehensive assessment of breast health.

What evidence suggests that MRI and mammography are effective for breast cancer screening in women with dense breasts?

This trial compares the effectiveness of two breast cancer screening methods: Abbreviated Breast MRI (AB-MR) and Digital Tomosynthesis Mammography (DBT). Studies have shown that a shorter version of breast MRI effectively detects breast cancer, correctly identifying cancer in up to 94.7% of cases. Research also indicates that this method can find more invasive cancers compared to some other imaging techniques. Meanwhile, digital tomosynthesis mammography, which creates 3D pictures of the breast, finds more cancers and has fewer false alarms than traditional 2D mammography. This trial will test the combination of both methods, potentially offering a better screening option for women with dense breast tissue by detecting more cases of cancer early. Participants in Arm A will undergo DBT followed by AB-MR, while those in Arm B will undergo AB-MR followed by DBT. ^{2 3 5 6 7}

Who Is on the Research Team?

Christopher Comstock

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9338668/

Evaluating the effectiveness of abbreviated breast MRI ... The per-breast analysis comparing readers' MRI classification with the true outcome (cancer or normal) showed an overall sensitivity of 86% (95%CI 84–87%; 1776/ ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11809753/

Accuracy of Abbreviated Breast MRI in Diagnosing ... A total of 19 women had pathology-proven breast cancer. Among all methods, ABMRI showed the highest sensitivity (94.7%) and specificity (58.3%), ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00582-3/fulltext

Comparison of supplemental breast cancer imaging ... Abbreviated MRI and contrast-enhanced mammography detected three times as many invasive cancers compared with ABUS, with cancers being half the ...

4. ajronline.org ajronline.org/doi/10.2214/AJR.21.26349

Implementation of Abbreviated Breast MRI for Screening: AJR ... For average-risk women with dense breasts and normal DBT, AB-MRI shows a CDR of up to 27.4 per 1000 women [11]. The potential role of AB-MRI in women at ...

5. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.221822

Abbreviated Breast MRI: State of the Art | Radiology Abbreviated MRI has been proposed to increase access to and tolerability of breast cancer screening or surveillance; published indications also ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8211370/

Abbreviated MR Imaging for Breast Cancer - PMC Abbreviated MR imaging has been shown to have similar diagnostic accuracy as full protocol MR imaging, with significantly shortened examination time.

7. densebreast-info.org densebreast-info.org/screening-technologies/breast-mri/

Breast MRI | DenseBreast-info, Inc ... Breast MRI reveals more cancers than any other screening test – averaging 10 additional cancers per thousand women screened, that were not seen ...