214 Participants Needed

MRI Screening for Brain Metastases in Breast Cancer

AA
IR
Overseen ByIvy Ricca, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the idea that MRI Screening for Brain Metastases in Breast Cancer is an effective treatment?

The available research shows that MRI is a valuable tool for detecting, characterizing, and monitoring brain metastases from breast cancer. It helps in diagnosing and assessing brain tumors, which is crucial for planning targeted therapies. MRI can identify different types of metastatic disease, which can lead to better treatment strategies. While MRI itself is not a treatment, it plays a critical role in guiding effective treatment decisions for brain metastases in breast cancer patients.12345

What safety data exists for MRI screening of brain metastases in breast cancer?

The provided research does not directly address safety data for MRI screening of brain metastases in breast cancer. However, MRI is described as the gold standard for diagnosing and assessing brain tumors, suggesting its established use in clinical settings. The studies focus on the detection and monitoring of brain metastases using MRI, highlighting its role in understanding metastatic burden and treatment responses. No specific safety concerns related to MRI itself are mentioned in the abstracts.13678

Is MRI screening a promising treatment for brain metastases in breast cancer?

Yes, MRI screening is a promising treatment for brain metastases in breast cancer. It helps in early detection, accurate diagnosis, and monitoring of brain tumors, which can lead to better-targeted therapies and improved patient outcomes. MRI can also track changes in tumor characteristics, aiding in personalized treatment plans.1291011

What is the purpose of this trial?

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).

Research Team

Ayal Aizer, MD, MHS - Dana-Farber ...

Ayal Aizer, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults over 18 with confirmed breast cancer, either starting first/second-line chemo for metastatic disease or managing inflammatory breast cancer. They must expect to live more than 12 weeks and agree to use birth control. It's not for those with MRI contraindications, severe kidney disease, gadolinium allergies, or existing brain metastases.

Inclusion Criteria

Participants must have a life expectancy of greater than 12 weeks.
Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
I am starting treatment for breast cancer that has spread or cannot be surgically removed.
See 3 more

Exclusion Criteria

Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.
I have been diagnosed with brain metastases before.
You have had a severe allergic reaction to gadolinium in the past.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial MRI Screening

Participants undergo an initial MRI screening of the brain to evaluate for metastases

1 week
1 visit (in-person)

Follow-up MRI Screening

Participants receive additional MRI screenings every six months for two years if no initial metastases are found

24 months
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

  • Magnetic Resonance Imaging
Trial Overview The study tests if MRI can effectively screen for the spread of breast cancer to the brain in patients undergoing certain treatments. The goal is to assess how useful MRI scans are in detecting these brain metastases early on.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Triple Negative Breast CancerExperimental Treatment1 Intervention
* An initial MRI screening will be conducted * If negative, patients will receive a second MRI of the brain at first systemic progression after study entry
Group II: Inflammatory Breast Cancer Managed with Curative IntentExperimental Treatment1 Intervention
* Patients will receive an initial screening magnetic resonance imaging (MRI) of the brain * If no evidence of intracranial involvement is identified, additional screening MRIs of the brain every six months for two years and at initial systemic progression.
Group III: HR+ or HER2+ Metastatic Breast Cancer - Screening ArmExperimental Treatment1 Intervention
* An initial MRI screening will be conducted * If negative, patients will receive a second MRI of the brain at first systemic progression after study entry
Group IV: HR+ or HER2+ Metastatic Breast Cancer - No Screening ArmActive Control1 Intervention
No initial MRI screening will be conducted

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

Conquer Cancer Foundation

Collaborator

Trials
22
Recruited
4,000+

Findings from Research

Preclinical imaging strategies have revealed three distinct types of brain metastases from breast cancer: permeable metastases, nonpermeable metastases, and solitary dormant cancer cells, each likely requiring different therapeutic approaches.
Current MRI techniques may not fully capture the extent of metastatic disease in the brain, suggesting that a better understanding of these metastases could lead to the development of more effective treatments that can cross the blood-brain barrier.
Brain metastases from breast cancer: lessons from experimental magnetic resonance imaging studies and clinical implications.Murrell, DH., Foster, PJ., Chambers, AF.[2021]
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.
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 patients undergoing GammaKnife™ MRI, 43.9% experienced growth of existing brain metastases, while 32.9% developed additional metastases, indicating a significant prevalence of disease progression.
Factors such as the initial brain metastasis velocity and the time between diagnostic MRI and GammaKnife MRI were linked to increased risks of new or enlarged brain metastases, but these changes did not significantly impact overall survival or the rate of distant intracranial failure.
Discovery of increased number or interval growth of brain metastases on same-day GammaKnife™ planning MRI: Predicting factors and patient outcomes.Mereniuk, TR., Burney, HN., Lautenschlaeger, T., et al.[2023]

References

Brain metastases from breast cancer: lessons from experimental magnetic resonance imaging studies and clinical implications. [2021]
Brain metastases from breast cancer using magnetic resonance imaging: A systematic review. [2023]
Discovery of increased number or interval growth of brain metastases on same-day GammaKnife™ planning MRI: Predicting factors and patient outcomes. [2023]
MRI evaluation of the effects of whole brain radiotherapy on breast cancer brain metastasis. [2020]
Radiographic markers of breast cancer brain metastases: relation to clinical characteristics and postoperative outcome. [2022]
Half brain irradiation in a murine model of breast cancer brain metastasis: magnetic resonance imaging and histological assessments of dose-response. [2018]
In-vivo longitudinal MRI study: an assessment of melanoma brain metastases in a clinically relevant mouse model. [2015]
MRI surveillance of cancer cell fate in a brain metastasis model after early radiotherapy. [2022]
Discordant and Converting Receptor Expressions in Brain Metastases from Breast Cancer: MRI-Based Non-Invasive Receptor Status Tracking. [2023]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
Screening of brain metastasis with limited magnetic resonance imaging (MRI): clinical implications of using limited brain MRI during initial staging for non-small cell lung cancer patients. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Time-delayed contrast-enhanced MRI improves detection of brain metastases and apparent treatment volumes. [2016]
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