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Low-field MRI for Breast Cancer Screening

N/A
Waitlist Available
Led By Matthew S Rosen, Ph.D
Research Sponsored by Massachusetts General Hospital
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 1 year
Awards & highlights

Study Summary

This trial is testing a new method of imaging breast cancer at an ultra-low magnetic field. The findings will be compared to results from standard mammograms, ultrasounds, MRIs, clinical examinations, and pathology evaluations. The ultra-low field breast MRI will not be used to guide clinical care.

Who is the study for?
This trial is for adult women aged 20-80, scheduled for breast imaging or biopsy, who can give informed consent and have no issues with small spaces. It's not for those with certain metal implants, electronic devices like pacemakers, a history of uncontrolled seizures, claustrophobia, pregnancy/breastfeeding or under 18/over 80.Check my eligibility
What is being tested?
The study is testing a new ultra-low field MRI technique to improve image quality in breast cancer screening. This method will be compared against standard mammograms and MRIs but won't influence current clinical care.See study design
What are the potential side effects?
There are minimal risks involved with the ultra-low magnetic fields used in this MRI technique. Unlike traditional high-field MRIs, there's little noise; however participants may experience discomfort due to the confined space.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
T1rho dispersion signal

Side effects data

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BREAST MRI IMAGES FROM PERSONS WITH KNOWN BREAST PATHOLOGIES BENIGN AND MALIGNANTExperimental Treatment1 Intervention
All participants will be recruited prior to their scheduled diagnostic imaging or diagnostic procedures. The expected time to complete the study is a maximum of 1.5 hours with approximately 30-60 minutes of scan time, depending on the specific MRI software being tested.
Group II: BREAST MRI IMAGES FROM HEALTHY VOLUNTEERSActive Control1 Intervention
All participants will be recruited prior to their scheduled diagnostic imaging or diagnostic procedures. The expected time to complete the study is a maximum of 1.5 hours with approximately 30-60 minutes of scan time, depending on the specific MRI software being tested.
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?

Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,601 Total Patients Enrolled
81 Trials studying Breast Cancer
132,912 Patients Enrolled for Breast Cancer
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,810 Total Patients Enrolled
50 Trials studying Breast Cancer
110,785 Patients Enrolled for Breast Cancer
Matthew S Rosen, Ph.DPrincipal InvestigatorMassachusetts General Hospital

Media Library

Magnetic Resonance Imaging (MRI) Clinical Trial Eligibility Overview. Trial Name: NCT05486520 — N/A
Breast Cancer Research Study Groups: BREAST MRI IMAGES FROM HEALTHY VOLUNTEERS, BREAST MRI IMAGES FROM PERSONS WITH KNOWN BREAST PATHOLOGIES BENIGN AND MALIGNANT
Breast Cancer Clinical Trial 2023: Magnetic Resonance Imaging (MRI) Highlights & Side Effects. Trial Name: NCT05486520 — N/A
Magnetic Resonance Imaging (MRI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05486520 — N/A

Frequently Asked Questions

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

Are there still opportunities to participate in this research initiative?

"The information available on clinicaltrials.gov states that this trial has ceased to accept new participants, last updated as of August 1st 2022. Despite the inactivity surrounding this research initiative, there are numerous other trials currently enrolling volunteers, numbering around 4536 all together."

Answered by AI

Does this research study permit individuals aged seventy and over to participate?

"As per the parameters of this research project, individuals between 20 and 80 years old are suitable for enrollment."

Answered by AI

Is there any way I might be qualified to participate in this clinical experiment?

"This clinical trial is recruiting 40 individuals with breast cancer aged between 20 and 80. Notably, all applicants must be informed about the minimal risks of ultra-low magnetic fields) and low-frequency nonionizing RF radiation involved in ultra-low field MR imaging as well as the small space within the magnet; there is also no sound produced by high-field scanners so hearing protection isn't necessary. Informed consent will be obtained from volunteer subjects through a detailed explanation on protocol purpose and potential benefits to society while adhering to HIPAA guidelines - allowing at least 15 minutes for consideration before participating or terminating studies without consequence present or future care/"

Answered by AI

Who else is applying?

What state do they live in?
New Hampshire
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Low-field MRI for Breast Cancer Screening
Matthew S. Rosen, Ph.D. 2022. "Low-field MRI for Breast Cancer Screening". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05486520.
~15 spots leftby Apr 2025
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