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

N/A
Waitlist Available
Led By Victoria Seewaldt, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial is testing if using breast tissue markers in combination with MRI can more accurately assess a woman's risk of developing breast cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
There may be minimal side effects related to the MRI procedure such as discomfort from lying still during the scan. Allergic reactions to gadolinium contrast used in MRIs are rare but possible; participants allergic to it cannot join.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of triple-negative breast cancer (invasive and/or ductal carcinoma in situ [DCIS]) within the 12-month period of the study
Secondary outcome measures
Expression of WNT10B/mutant p53 in morphologically normal breast tissue
Other outcome measures
Predictive accuracy of WNT10B with magnetic resonance imaging (MRI)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (breast MRI, biopsy)Experimental Treatment3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biospecimen Collection
2004
Completed Phase 2
~1720

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,020 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,272 Total Patients Enrolled
Victoria Seewaldt, MDPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
161 Total Patients Enrolled

Media Library

Magnetic Resonance Imaging Clinical Trial Eligibility Overview. Trial Name: NCT03303846 — N/A
Healthy Subjects Research Study Groups: Treatment (breast MRI, biopsy)
Healthy Subjects Clinical Trial 2023: Magnetic Resonance Imaging Highlights & Side Effects. Trial Name: NCT03303846 — N/A
Magnetic Resonance Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT03303846 — N/A
Healthy Subjects Patient Testimony for trial: Trial Name: NCT03303846 — N/A
~74 spots leftby Apr 2026
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