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

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

344 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment involving MRI and biomarker analysis for identifying high-risk individuals among healthy subjects?

Research shows that MRI is effective in screening for breast cancer in women at genetic risk, suggesting its potential usefulness in identifying high-risk individuals in other contexts. Additionally, MRI has been used to assess tumor volume in cervical cancer, indicating its capability in detecting and evaluating cancer-related changes. ^{1 2 3 4 5}

What safety data exists for MRI and related procedures?

MRI procedures, including those using gadolinium-based contrast agents (GBCAs), generally have a good safety record, but there are risks such as allergic reactions and issues for people with kidney problems. It's important to follow safety guidelines to prevent accidents, especially for those with implants or devices. ^{6 7 8 9 10}

How does the MRI + Biomarker Analysis treatment differ from other treatments for identifying high-risk individuals?

This treatment is unique because it combines MRI (magnetic resonance imaging) with biomarker analysis to identify high-risk individuals among healthy subjects, which is not a standard approach for this purpose. Unlike traditional methods that may rely solely on physical exams or basic imaging, this approach uses advanced imaging techniques and biological markers to provide a more comprehensive assessment. ^{11 12 13 14 15}

What is the purpose of this trial?

This clinical trial studies normal breast tissue changes combined with breast magnetic resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast tissue markers in combination with breast imaging such as MRI may help to more accurately assess a woman's risk of developing breast cancer.

Research Team

Victoria L Seewaldt, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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Safety issues related to intravenous contrast agent use in magnetic resonance imaging. [2021]

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Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]

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Gadolinium-based Contrast Agents for Cardiac MRI: Use of Linear and Macrocyclic Agents with Associated Safety Profile from 154 779 European Patients. [2022]

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