MRI Screening for Brain Metastases in Breast Cancer

(SYMPToM Trial)

Overseen By Ellen Warner, MD FRCPC MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Severe claustrophobia, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether regular MRI scans of the brain can detect early signs of cancer spread in women with certain types of metastatic breast cancer. Participants will either receive MRI scans every four months or only if they exhibit symptoms of brain issues, such as headaches or vision changes. The study aims to determine if early detection through MRI can improve quality of life and extend survival. Women with HER2+ or triple-negative breast cancer that has spread beyond the breast and nearby areas, but without current brain symptoms, may be suitable for this study.

As an unphased trial, this study offers the opportunity to contribute to important research that could lead to better early detection methods for others in the future.

Will I have to stop taking my current medications?

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 screening technique is safe for detecting brain metastases in breast cancer patients?

Research has shown that MRI scans for detecting brain metastases in patients with metastatic breast cancer are generally safe. MRI uses strong magnets and radio waves to create detailed images of the brain. As a non-invasive procedure, it does not involve surgery or entering the body, and patients in past studies have tolerated it well without major side effects.

Unlike CT scans, MRI does not use radiation, which is a common concern for many people. This makes MRI a safer choice for repeated scans. Advanced MRI techniques, such as Chemical Exchange Saturation Transfer (CEST), enhance the detection of brain metastases without adding risk.

Overall, MRI scans have a strong safety record, making them a reliable option for monitoring patients at risk for brain metastases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MRI screening for brain metastases in breast cancer because it offers a proactive approach to detecting potential issues before symptoms even appear. Unlike the traditional symptom-directed surveillance, where imaging happens only after symptoms develop, this method uses contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI at regular intervals. This could potentially allow for earlier detection and treatment, improving patient outcomes and opening new avenues for managing brain metastases in breast cancer.

What evidence suggests that MRI screening is effective for detecting brain metastases in breast cancer?

Research has shown that MRI scans can detect cancer that has spread to the brain from breast cancer at an early stage. One study found that 14% of patients with metastatic breast cancer had brain metastases detected through regular brain MRIs, despite having no symptoms. This included 18% of patients with triple-negative breast cancer and 15% with HER2+ breast cancer. In this trial, participants in the MRI screening arm will undergo regular MRI scans to potentially find brain metastases early, which might help manage symptoms sooner and possibly improve quality of life. Some MRI results can also provide information about patient outcomes, such as the likelihood of cancer returning or changes in cognitive ability. ^{1 2 6 7 8}

Who Is on the Research Team?

Katarzya J Jerzak, MD MSc FRCPC

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for women over 18 with HER2+ or triple negative metastatic breast cancer, diagnosed within the last 12 weeks and without symptoms or known brain metastases. It's not open to those with other cancers that could affect the study results.

Inclusion Criteria

My breast cancer is either triple negative or HER2 positive.

My cancer spread to other parts was diagnosed within the last 3 months.

My breast cancer has spread beyond the breast and nearby lymph nodes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either routine MRI screening every 4 months or symptom-directed surveillance for brain metastases

12 months

Baseline, 4 months, 8 months, 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• MRI screening

Trial Overview The study compares routine MRI screening every four months against MRIs only when symptoms appear, in detecting brain metastases early. Participants will also provide blood samples and complete questionnaires on life quality and anxiety.

How Is the Trial Designed?

Group I: MRI screening Experimental Treatment 1 Intervention

Contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain at baseline, 4 months, 8 months and 12 months.

Group II: Symptom-directed surveillance Active Control 1 Intervention

Imaging of the brain will take place only if patients develop symptoms that are suggestive of brain metastases (e.g. headaches, vision changes, gait instability).

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Harvard University

Collaborator

Trials

237

Recruited

588,000+

Published Research Related to This Trial

MRI screening for high-risk women can significantly increase the detection of breast cancers, particularly identifying cancers before they spread to lymph nodes.

While MRI offers benefits in cancer detection, it also carries risks of false positives, which may result in unnecessary additional imaging or benign biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening MRI for women at high risk for breast cancer. Lehman, CD.[2019]

In a study of 88 female patients with breast cancer who underwent surgery for brain metastases, the presence of intra-tumoral necrosis was found to be significantly associated with overall survival, with a median survival of 14.5 months for those with necrosis compared to 22.5 months for those without.

The study also revealed that certain characteristics, such as a shorter time interval between breast cancer diagnosis and brain metastases and preoperative leukocytosis, were linked to the presence of necrosis, indicating that radiographic features on MRI can reflect underlying tumor biology and patient prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic markers of breast cancer brain metastases: relation to clinical characteristics and postoperative outcome. Michel, A., Dinger, T., Darkwah Oppong, M., et al.[2022]

A systematic review of 24 studies involving 1580 breast cancer patients with brain metastases (BMs) highlighted that MRI is crucial for detecting and characterizing BMs, with findings varying based on the MRI technique used, the subtype of breast cancer, and the characteristics of the lesions.

Certain MRI findings were linked to prognosis and cognitive impairment in patients, indicating that MRI not only aids in diagnosis but also has potential implications for treatment strategies and understanding the biology of breast cancer metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain metastases from breast cancer using magnetic resonance imaging: A systematic review. Mohammadi, M., Mohammadi, S., Hadizadeh, H., et al.[2023]

In a study of 142 breast cancer patients with leptomeningeal metastases, the use of the 2019 revised RANO LM criteria to assess treatment response showed a significant correlation with overall survival, indicating its effectiveness as a prognostic tool.

Patients who achieved a complete response had a median overall survival of 31.1 months, while those with progressive disease had a median survival of only 9.5 months, highlighting the importance of radiological response in predicting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiological response of leptomeningeal metastases according to revised RANO criteria is associated with overall survival in breast cancer patients. Griguolo, G., Aldegheri, V., Bottosso, M., et al.[2023]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00356

Brain Imaging Surveillance for Patients With Metastatic ... Patients with MBC and brain metastases were also more likely to have neurologic symptoms (75.9% v 60.5%; P < .001) than those with NSCLC.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10920938/

Brain metastases from breast cancer using magnetic ... Some MRI findings were associated with prognosis, recurrence or cognitive impairment in BC patients with BMs. MRI detects, characterises and monitors BMs from ...

3. thebreastonline.com thebreastonline.com/article/S0960-9776(25)00575-2/fulltext

Brain imaging screening in metastatic breast cancer Notably, 91 % of patients would like to receive information regarding BM, while only 13 % of physicians routinely address the issue. Conclusions.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04030507

NCT04030507 | Screening Magnetic Resonance Imaging ... This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).

5. academic.oup.com academic.oup.com/neuro-oncology/article/27/6/1550/7978292?rss=1

Phase II trial of brain MRI surveillance in stage IV breast cancer The overall frequency of brain metastasis on initial surveillance brain MRI was 14% (n = 14) with rates of 18%, 15%, and 10% in TNBC, HER2+, and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39851040/

Phase II trial of brain MRI surveillance in stage IV breast ... The overall frequency of brain metastasis on initial surveillance brain MRI was 14% (n = 14) with rates of 18%, 15%, and 10% in TN, HER2+, and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625005752

Brain imaging screening in metastatic breast cancer Screening magnetic resonance imaging of the brain in patients with metastatic breast cancer managed with first/second line chemotherapy or ...

8. cancertreatmentreviews.com cancertreatmentreviews.com/article/S0305-7372(24)00189-0/fulltext

Expert consensus on the prevention of brain metastases in ... MRI screening versus symptom-directed surveillance for brain metastases among patients with triple negative or HER2+ metastatic breast cancer: A ...