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Imaging

RSI vs MRI for Breast Cancer Screening

N/A

Waitlist Available

Led By Vandana Dialani, MD

Research Sponsored by Beth Israel Deaconess 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 2 years

Awards & highlights

Study Summary

This trial is testing RSI as a possible alternative to breast MRI.

Who is the study for?

This trial is for women aged 18 or older who are asymptomatic for breast disease and due for routine screening with MRI or mammogram/ultrasound. Radiologists participating must have experience in interpreting breast MRIs. Women with breast implants, claustrophobia, renal insufficiency, unsafe devices for MRI, planned biopsies before the study, pregnancy/nursing status, or history of reaction to gadolinium contrast cannot participate.Check my eligibility

What is being tested?

The study compares Restriction Spectrum Imaging (RSI), a potential new technique for breast cancer screening, against the conventional Breast Magnetic Resonance Imaging (MRI) that healthcare professionals currently use.See study design

What are the potential side effects?

Since RSI is an imaging technique similar to MRI without using intravenous contrast agents like gadolinium used in standard MRIs, it may reduce the risk of side effects related to these agents such as allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Diagnostic accuracy of breast restriction spectrum imaging (RSI) in comparison to conventional breast MRI

Secondary outcome measures

Diagnostic accuracy of RSI compared to that of abbreviated MRI (Ab-MRI) in breast cancer screening

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SCREENING MG BI-RADS 4/5Experimental Treatment1 Intervention

RSI is a DWI sequence with a built in distortion-correction technique that can be applied to any diffusion technique using echo planar imaging acquisition. RSI will be performed using pulsed-field gradient, spin-echo, echo planar imaging with "multi-shell" diffusion data . The b0 images will be collected in both the forward and reverse phase encoding directions to allow for post-processing correction of spatial distortion from magnetic field.

Group II: SCREENING MRIActive Control1 Intervention

Standard MRI procedure will be used.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RSI

2008

Completed Phase 4

~230

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER

1,079 Previous Clinical Trials

340,038 Total Patients Enrolled

141 Trials studying Breast Cancer

21,707 Patients Enrolled for Breast Cancer

Beth Israel Deaconess Medical CenterLead Sponsor

836 Previous Clinical Trials

13,009,426 Total Patients Enrolled

47 Trials studying Breast Cancer

6,355 Patients Enrolled for Breast Cancer

Radiological Society of North AmericaOTHER

25 Previous Clinical Trials

909 Total Patients Enrolled

1 Trials studying Breast Cancer

100 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Research Study Groups: SCREENING MRI, SCREENING MG BI-RADS 4/5

Magnetic Resonance Imaging (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03495115 — N/A

Frequently Asked Questions

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

Is there currently an opportunity to enroll in this scientific experiment?

"Unfortunately, according to clinicaltrials.gov this trial is no longer enrolling patients; it was originally posted on April 18th 2018 and last updated August 17 2021. However, at present there are 2,602 other medical studies actively recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Restriction Spectrum Imaging (RSI) to Conventional and Abbreviated Breast MRI for Breast Cancer Screening

Vandana Dialani 2018. "Comparing Restriction Spectrum Imaging (RSI) to Conventional and Abbreviated Breast MRI for Breast Cancer Screening". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03495115.