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Supine MRI for Breast Cancer (21DIF039 Trial)

N/A

Waitlist Available

Led By Roberta diFlorio-Alexander, MD

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Female gender

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of mri, 1 day

Awards & highlights

21DIF039 Trial Summary

This trial tests if MRI can accurately show tumors in the breast, to help create devices that guide surgeons to remove them. #breastcancer

Who is the study for?

This trial is for women over 18 with invasive breast cancer or ductal carcinoma in situ, where the tumor is at least 1 cm on mammogram/US. Participants must need a pre-op breast MRI and can consent to the study. It's not for those with severe claustrophobia, prior neoadjuvant chemotherapy for current diagnosis, contraindications to MRI or gadolinium contrast, history of NSF, sternotomy, pregnancy (confirmed by test if unsure), or poor kidney function.Check my eligibility

What is being tested?

The trial tests if a supine breast MRI after a standard prone MRI can help radiologists accurately outline tumor edges using an additional injection of gadolinium contrast. This could assist in creating a 3-D image of the tumor for developing surgical devices that aid in removing breast cancers.See study design

What are the potential side effects?

Potential side effects may include reactions to gadolinium contrast such as nausea, headache, pain at injection site or allergic reactions. There might also be discomfort from lying still during the MRIs and anxiety related to being in an enclosed space.

21DIF039 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I am female.

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I can willingly sign the consent form before any study tests or procedures.

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I have been diagnosed with invasive breast cancer or ductal carcinoma in situ.

21DIF039 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of mri, 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of mri, 1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of mri, 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in mean tumor-to-fibroglandular contrast ratio in prone compared to supine breast MRI

Secondary outcome measures

Evaluate tumor visualization and segmentability on supine breast MRI exam with additional contrast injection obtained immediately after prone contrast breast MRI, and compare to tumor visualization and segmentability on clinical prone breast MRI.

Other outcome measures

Evaluate time required for double contrast prone to supine exam compared to single contrast prone to supine exam.

21DIF039 Trial Design

1Treatment groups

Experimental Treatment

Group I: Supine MRIExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Supine MRI

2016

N/A

~220

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor

524 Previous Clinical Trials

2,543,296 Total Patients Enrolled

29 Trials studying Breast Cancer

2,352,830 Patients Enrolled for Breast Cancer

CairnSurgical, Inc.Industry Sponsor

1 Previous Clinical Trials

448 Total Patients Enrolled

Roberta diFlorio-Alexander, MDPrincipal InvestigatorDHMC

Media Library

Supine MRI Clinical Trial Eligibility Overview. Trial Name: NCT05131607 — N/A

Breast Cancer Research Study Groups: Supine MRI

Breast Cancer Clinical Trial 2023: Supine MRI Highlights & Side Effects. Trial Name: NCT05131607 — N/A

Supine MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT05131607 — N/A

Frequently Asked Questions

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

How many people have been accepted to participate in this medical experiment?

"Affirmative, current records on clinicaltrials.gov confirm that this medical trial is actively recruiting patients since its initial posting on March 17th 2022 and most recent update of July 5th 2023. 60 individuals need to be enrolled at a single site for the study's completion."

Answered by AI

Is this research endeavor open to new participants?

"According to the details found on clinicaltrials.gov, this research study is actively looking for volunteers and has been doing so since March 17th 2022. It was last updated on July 5th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

21DIF039: Prone to Supine Breast MRI II, P2S2 Breast MRI Trial

Roberta diFlorio-Alexander 2022. "21DIF039: Prone to Supine Breast MRI II, P2S2 Breast MRI Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05131607.