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MRI Surveillance for High-Risk Breast Cancer (CAPS Trial)

N/A
Recruiting
Led By Olufunmilayo I Olopade, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with history of chest wall radiation received before age 35
Known BRCA1 or BRCA2, TP53, PALB2, PTEN, CDH1 and STK11 carrier. Women with pathogenic mutations in any other cancer susceptibility genes are eligible only if they also have a high PRS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

CAPS Trial Summary

This trial will help detect breast cancer earlier in high-risk women.

Who is the study for?
This trial is for women at high risk of breast cancer, including those with a history of breast or ovarian cancer who are now cancer-free for two years, have had chest radiation before age 35, or carry certain genetic mutations. African Ancestry women under 45 with family history of these cancers are also eligible. Participants must be willing to travel for imaging studies and follow-up procedures, give informed consent, and meet specific risk criteria based on genetic and non-genetic factors.Check my eligibility
What is being tested?
The study is establishing a registry to monitor high-risk women using intensive surveillance methods like Magnetic Resonance Imaging (MRI) to detect early signs of breast cancer. It aims to improve early detection in those who have a significantly higher chance due to personal or familial factors.See study design
What are the potential side effects?
Since the intervention involves MRI scans which do not use ionizing radiation like X-rays or CT scans, they're generally considered safe with few side effects. However, some individuals may experience discomfort from lying still during the procedure or claustrophobia.

CAPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I received radiation on my chest before I was 35.
Select...
I carry mutations in specific genes linked to cancer risk.
Select...
My risk of developing the condition in the next 5 years is 6% or higher.
Select...
I am at least 25 years old.

CAPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Development of faster MRI protocols for a for a Personalized Risk-based Imaging Surveillance Model for diverse populations of high risk women.
Secondary outcome measures
Calculation of total healthcare costs for woman under going biannual (2x per year) screening for breast cancer

Side effects data

From 2017 Phase 4 trial • 12 Patients • NCT01895959
8%
knee pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment

CAPS Trial Design

1Treatment groups
Experimental Treatment
Group I: Screening ArmExperimental Treatment1 Intervention
Enrolled patients will undergo Magnetic Resonance Imaging (MRI) every 6 months (2x/year) in addition to an annual screening mammogram.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging (MRI)
2015
Completed Phase 4
~1800

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,476 Total Patients Enrolled
49 Trials studying Breast Cancer
110,385 Patients Enrolled for Breast Cancer
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,377 Total Patients Enrolled
25 Trials studying Breast Cancer
4,359 Patients Enrolled for Breast Cancer
Olufunmilayo I Olopade, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
78 Total Patients Enrolled
2 Trials studying Breast Cancer
78 Patients Enrolled for Breast Cancer

Media Library

Magnetic Resonance Imaging (MRI) Clinical Trial Eligibility Overview. Trial Name: NCT03729115 — N/A
Breast Cancer Research Study Groups: Screening Arm
Breast Cancer Clinical Trial 2023: Magnetic Resonance Imaging (MRI) Highlights & Side Effects. Trial Name: NCT03729115 — N/A
Magnetic Resonance Imaging (MRI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03729115 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer
2019. "A Multi-Modality Surveillance Program for Women at High Risk for Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03729115.
All > Breast Cancer Chicago
~195 spots leftby Dec 2028
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