MRI + Biomarker Analysis for Identifying High-Risk Individuals Among Healthy Subjects

Not currently recruiting at 4 trial locations

Overseen By Ruth O'Regan, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Must not be taking: Cytotoxic chemotherapy, Endocrine therapy

Disqualifiers: Active cancer, Stage 4 cancer, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify early signs of breast cancer by examining changes in normal breast tissue through MRI scans (Magnetic Resonance Imaging) and tissue markers. The researchers seek to better predict breast cancer risk among women already considered high-risk and undergoing routine MRI screenings. Women who receive breast MRI scans for high-risk screening and are willing to donate extra tissue and provide a small blood sample may be suitable for this trial. As an unphased trial, participants can contribute to groundbreaking research that may enhance early detection methods for breast cancer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have received cytotoxic chemotherapy or endocrine therapy within the past year, you may not be eligible to participate.

What prior data suggests that this MRI and biomarker analysis is safe for identifying high-risk individuals?

Research has shown that breast MRI (magnetic resonance imaging) safely checks for signs of breast cancer. It uses magnets and radio waves to create images. Although generally safe, it can sometimes cause false alarms, suggesting a problem when there isn't one, which may lead to additional tests like ultrasounds or biopsies (taking small tissue samples).

Collecting and studying samples, such as blood or tissue, are standard methods for identifying signs of diseases like cancer. The collection process is typically straightforward and follows standard procedures.

Both methods are commonly used in medical research, and studies have not reported major safety concerns with their use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines MRI scans with biomarker analysis to identify high-risk individuals for breast cancer before any symptoms appear. Unlike standard screenings, which typically focus on imaging alone, this approach uses blood and tissue samples to uncover specific biological markers that might indicate a higher risk. This method could lead to earlier and potentially more accurate detection, allowing for timely intervention and personalized treatment plans. By integrating these advanced techniques, the trial aims to enhance early detection capabilities beyond what current methods can achieve.

What evidence suggests that MRI and biomarker analysis are effective for identifying high-risk individuals for breast cancer?

Research has shown that MRI scans can effectively detect early breast cancer, particularly in women at high risk. In this trial, participants will undergo standard high-risk breast cancer screening MRIs at baseline and follow-up. Studies have found that MRI alone can detect more breast cancer cases than mammograms (breast X-rays). For instance, one study found that MRI detected eight more cases per 1,000 women than mammograms alone. Another study reported a detection rate of 9.5 cases per 1,000 women per year. These findings suggest that MRI can be a valuable tool for identifying early signs of breast cancer, potentially leading to better outcomes for those at high risk. ^{6 7 8 9 10}

Who Is on the Research Team?

Victoria L Seewaldt, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for women at high risk of breast cancer who are willing to donate blood and leftover tissue from biopsies or surgeries. They must be undergoing standard screening with MRI, not have stage 4 cancer, active cancer (except certain skin cancers), recent chemo or endocrine therapy, recent radiation, pregnancy or lactation within the last year.

Inclusion Criteria

I am willing to donate leftover tissue from my breast biopsy or surgery.

Willing to have about 40 mL of blood (approximately 3 tablespoons) drawn

I am getting a breast MRI because I'm at high risk for breast cancer.

Exclusion Criteria

Pregnant and/or lactating within 1 year prior to screening breast MRI

Receives screening breast MRIs at an outside facility other than the consenting institution

I have an active cancer diagnosis, except for certain skin cancers and early breast changes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo standard of care high risk breast cancer screening MRIs and blood sample collection at baseline

1 week

1 visit (in-person)

Follow-up

Participants undergo follow-up breast MRIs and collection of breast tissue samples at any breast biopsy or surgery

12 months

Multiple visits as needed for biopsies or surgeries

What Are the Treatments Tested in This Trial?

Interventions

• Biospecimen Collection
• Laboratory Biomarker Analysis
• Magnetic Resonance Imaging

Trial Overview The study is testing if combining breast MRI scans with analysis of biomarkers in blood and tissue can better identify women at high risk for developing breast cancer. It aims to improve early detection by correlating imaging results with molecular changes.

How Is the Trial Designed?

Group I: Treatment (breast MRI, biopsy) Experimental Treatment 3 Interventions

Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants also undergo collection of breast tissue samples at any breast biopsy or breast surgery.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 1334 cardiovascular magnetic resonance (CMR) procedures for patients with congenital heart disease, the overall incidence of adverse events (AEs) was low at 1.6%, with most being minor in severity.

The use of general anesthesia and the status of being an inpatient were identified as independent risk factors for experiencing AEs, particularly in the most critically ill patients, highlighting the need for careful monitoring in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. Dorfman, AL., Odegard, KC., Powell, AJ., et al.[2013]

Recent advancements in magnetic resonance (MR) technology have led to stronger magnetic fields and improved safety features, but most MR-related injuries and fatalities are due to non-compliance with safety guidelines.

To enhance safety in MR environments, it is crucial to update and revise safety information regarding biological effects and the compatibility of biomedical implants and devices with current MR technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR procedures: biologic effects, safety, and patient care. Shellock, FG., Crues, JV.[2008]

In a study of 154,779 patients undergoing cardiac MRI, gadolinium-based contrast agents (GBCAs) were used in 94.2% of cases, with a significant shift towards macrocyclic agents following regulatory changes, which showed a favorable acute safety profile.

The overall rate of acute adverse events (AAEs) associated with GBCAs was low at 0.36%, with severe events occurring in only 0.03% of patients, indicating that GBCAs, particularly macrocyclic types, are generally safe for use in cardiac imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadolinium-based Contrast Agents for Cardiac MRI: Use of Linear and Macrocyclic Agents with Associated Safety Profile from 154 779 European Patients. Uhlig, J., Al-Bourini, O., Salgado, R., et al.[2022]

Gadolinium-based contrast agents (GBCAs) have a strong safety record in MRI imaging, but there are known risks such as acute adverse reactions and nephrogenic systemic fibrosis that require ongoing management and understanding.

The review highlights that certain populations, including those with kidney issues, are at higher risk for complications from GBCAs, and it also discusses the emerging use of ferumoxytol as a non-GBCA alternative with its own risk profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues related to intravenous contrast agent use in magnetic resonance imaging. Ponrartana, S., Moore, MM., Chan, SS., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38142230/

Outcomes of High-Risk Breast MRI Screening in Women ... High-risk screening breast MRI was effective at detecting early breast cancer and associated with favorable outcomes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9997824/

Magnetic resonance imaging in screening women at high ... Among the 1000 screened women, MRI alone increased the detection rate of breast cancer by 8 compared with mammography alone (RR 0.48, 95% CI ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa031759

Efficacy of MRI and Mammography for Breast-Cancer ... The overall rate of detection for all breast cancers (invasive plus in situ) was 9.5 per 1000 woman-years at risk (95 percent confidence interval, 7.1 to 12.3), ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06629896

Contrast Enhancement Mammography vs MRI for the ... Women at high risk of breast cancer (BC) should undergo annual magnetic resonance imaging (MRI) and digital mammography (DM) from at least ages 35 to 60.

5. insightsimaging.springeropen.com insightsimaging.springeropen.com/counter/pdf/10.1186/s13244-024-01653-4.pdf?utm_source=consensus

The paradox of MRI for breast cancer screening In. 2019, the results of the “DENSE” RCT were published in favour of breast MRI screening of women with extremely dense breasts compared to mammography alone, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04074720

Prospective Breast Cancer Biospecimen Collection Collected biospecimens will be analyzed using current laboratory techniques to identify the presence of breast cancer biomarkers such as estrogen receptor (ER) ...

7. withpower.com withpower.com/trial/phase-9-2017-6942d

MRI + Biomarker Analysis for Identifying High-Risk Individuals ... Research shows that MRI is effective in screening for breast cancer in women at genetic risk, suggesting its potential usefulness in identifying high-risk ...

8. reporter.nih.gov reporter.nih.gov/project-details/11176766

Biospecimen Core Samples collected include fresh, fresh-frozen, cryopreserved and formalin-fixed paraffin embedded specimens from 1) treated or untreated breast cancers with ...

9. grants.nih.gov grants.nih.gov/grants/guide/pa-files/PAR-25-325.html

PAR-25-325: Integrating Biospecimen Science ... The overall goal is to expedite biomarker clinical assay development through evidence-based standardization of biopsy handling practices.

10. dctd.cancer.gov dctd.cancer.gov/data-tools-biospecimens/biospecimens-biobanks/resources/best-practices/best-practices-2016.pdf

NCI Best Practices for Biospecimen Resources A system upgrade should include re-testing of updated program elements and any high risk areas of the ... funded biospecimen resources for high-quality ...