Preoperative Breast MRI for Breast Cancer

No longer recruiting at 3 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Age 60+, Pregnant, MRI contraindications, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how often MRI (Magnetic Resonance Imaging) scans detect hidden cancer areas in women with one known area of breast cancer. It also investigates how these MRI findings might alter treatment plans. Researchers will follow participants over 10 years to monitor cancer recurrence. Ideal candidates are women under 60 with early-stage breast cancer (Stage 0 or Stage I) who are scheduled for surgery at a specific cancer center.

As an unphased trial, this study allows participants to contribute to important research that could enhance future breast cancer detection and treatment strategies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this MRI is safe for breast cancer patients?

Research has shown that a breast MRI before surgery is safe for patients. Studies have found that an MRI before surgery does not alter survival rates or increase the number of surgeries. Patients generally handle the MRI process well.

Although an MRI might not change the surgery plan or long-term outcomes, it helps doctors identify areas of breast cancer that other tests might miss. This makes it a valuable tool for planning treatment, even though it does not directly impact safety. Overall, MRI is a common and safe technology for breast cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using preoperative breast MRI for breast cancer because it offers a more detailed look at the breast tissue before surgery. Unlike traditional imaging methods like mammograms or ultrasounds, MRI can provide a clearer picture of the extent of ductal carcinoma in situ (DCIS) and any potential microinvasion. This enhanced imaging capability helps surgeons plan more precise operations, potentially leading to better surgical outcomes and reducing the need for follow-up surgeries. By improving the accuracy of breast cancer surgery, MRI could lead to more effective treatment plans tailored to each patient's unique situation.

What evidence suggests that MRI is effective for detecting additional areas of breast cancer?

Studies have shown that a breast MRI before surgery effectively finds areas of breast cancer that other scans might miss. For example, research indicates that MRI can correctly identify 98% of certain early-stage breast cancers, while traditional mammograms identify only 52%. Additionally, MRI helps doctors determine which early-stage cancers are more likely to become invasive. Using MRI before surgery also reduces the chances of needing another operation later. This trial will evaluate the effectiveness of preoperative breast MRI in women with core biopsy-proven DCIS, with or without microinvasion, seen for surgical consultation. These findings suggest that breast MRI is a powerful tool for planning effective breast cancer treatment. ^{5 6 7 8 9}

Who Is on the Research Team?

Kimberly Van Zee, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for women under 60 with a specific breast cancer diagnosis (DCIS or DCIS with microinvasion) who haven't had certain biopsies or surgeries yet. They must be able to have breast surgery at MSKCC and not be pregnant, nursing, or have conditions that make MRI unsafe like pacemakers, metal implants, severe weight over 350 lb., allergies to MRI contrast agents, or metal in the eye.

Inclusion Criteria

I am under 60 years old.

My breast surgery will be done at MSKCC.

I am female.

Exclusion Criteria

I am 60 years old or older.

I cannot have breast-saving surgery due to my condition.

I had a surgical biopsy for DCIS or DCIS with slight invasion before joining.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative MRI Assessment

Participants undergo MRI to detect additional areas of cancer and assess treatment impact

1-2 weeks

1 visit (in-person)

Surgical Intervention

Participants undergo planned surgical intervention based on MRI findings

1 week

1 visit (in-person)

Follow-up

Participants are monitored for recurrence of breast cancer over a 10-year period

10 years

What Are the Treatments Tested in This Trial?

Interventions

• MRI

Trial Overview The study tests how effective Breast MRI is in detecting additional cancer areas in women already diagnosed with one area of breast cancer. It examines if the MRI influences treatment decisions and compares image findings with microscopic tissue analysis. Participants will also be followed for ten years to monitor cancer recurrence.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

Women with core biopsy proven DCIS with or without microinvasion seen for surgical consultation at Memorial Sloan-Kettering Cancer Center and for whom operative intervention is planned.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. i-mri.org i-mri.org/DOIx.php?id=10.13104/imri.2024.0025

The Role of Preoperative Breast MRI in Patients With Early- ... The findings indicated that preoperative MRI was associated with a higher likelihood of undergoing ipsilateral mastectomy (odds ratio [OR], 1.39 ...

2. nature.com nature.com/articles/s41523-024-00677-9

Magnetic resonance imaging insights from active ... MRI imaging features in patients treated with ET and undergoing AS, may help determine which DCIS lesions are at low versus high risk for IDC.

3. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.2017161449

Impact of Preoperative Breast MR Imaging and MR-guided ... Breast MR imaging improves depiction of DCIS components of invasive breast cancers before surgery and is associated with positive margin and mastectomy rates.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5161071/

Magnetic Resonance Imaging in the Evaluation of Ductal ... In patients with high-grade or comedo-type DCIS, the sensitivity of MRI was 98% compared with only 52% for mammography. The majority (87%) of cases of DCIS not ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0720048X20302473

Cost-effectiveness of preoperative magnetic resonance ... In brief, the re-intervention rate for close or positive margins was 20% in MRI arm and 27% in control arm, i.e. a relative reduction of 26% (stratified OR 0.68 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10036439/

Effects of preoperative magnetic resonance image on survival ... The use of preoperative MRI did not influence local relapse-free survival, overall survival, or reoperation rates. Keywords: Magnetic resonance ...

7. cancernetwork.com cancernetwork.com/view/preoperative-breast-mri-does-not-improve-surgical-plan-local-control

Preoperative Breast MRI Does Not Improve Surgical Plan ... An additional study revealed that preoperative breast MRI had no impact on 15-year outcomes for BCS-managed DCIS (P = .25) or early-stage breast ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8474971/

Preoperative Breast MRI for Newly Diagnosed Ductal ... Primary results indicated that overall mastectomy conversion was 19.2% after MRI (MRI findings accounted for 38.5% conversions), with a WLE ...

9. nature.com nature.com/articles/s41523-020-00192-7

Preoperative magnetic resonance imaging use and ... The meta-analysis, and the individual studies. showed no benefit for MRI use in the prevention of subsequent breast cancer events. Only two of ...