← Back to Search

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

N/A
Recruiting
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
~1180
Biospecimen Collection
2004
Completed Phase 2
~1920

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,917,602 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,926,697 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In which geographic areas is this trial being conducted?

"This clinical trial is currently operating at 5 sites, including the University of Wisconsin in Madison, Ohio State University and Stefanie Spielman Comprehensive Breast Center in Columbus. Other participating locations include Duke University in Durham."

Answered by AI

How many participants are taking part in this research study?

"The trial necessitates 650 participants, meeting the pre-set inclusion criteria. These individuals can register at either University of Wisconsin in Madison or Ohio State University’s Stefanie Spielman Comprehensive Breast Center in Columbus."

Answered by AI

Are researchers looking to recruit more participants for this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this research study is actively recruiting and was first posted in October of 2017. 650 patients are needed at 5 different sites for successful completion of the trial."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
North Carolina
California
How old are they?
65+
18 - 65
What site did they apply to?
Other
Duke University
City of Hope Medical Center
University of Southern California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0

What questions have other patients asked about this trial?

HOW LONG ARE VISITS AND WHAT'S THE COMPENSATION?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I am looking to volunteer. INTERESTED IN HELPING SUBJECTS. To help other people find cures and treatments.
PatientReceived 2+ prior treatments
I feel strongly that any clinical trials I am eligible for that might advance treatment is a privilege.
PatientReceived 2+ prior treatments
~153 spots leftby Apr 2026