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MRg-NIRS Imaging for Breast Cancer (MRg-NIRS Trial)

N/A
Waitlist Available
Led By Keith D. Paulsen, PhD
Research Sponsored by Keith D. Paulsen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females age ≥ 18 years old
Women with a recent diagnosis of breast cancer
Must not have
Personal history of breast cancer in the ipsilateral breast
Participants with absolute or relative contraindication to MRI: the presence of an electronic implant, such as a pacemaker; the presence of a metal implant, such as an aneurysm clip; claustrophobia; renal failure (FDA's guidance for gadolinium of a creatinine clearance less than 30 mL/1.73 m2 BSA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one hour on day of mri
Awards & highlights

Summary

This trial involves studying 20 women with breast cancer to see if adding a special imaging technique called MR-guided near-infrared spectroscopy can help improve the way breast MRI scans are used to manage their

Who is the study for?
This trial is for women diagnosed with breast cancer. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and be able to undergo MRI procedures.
What is being tested?
The study is testing the use of a new imaging system called MRg-NIRS in women with breast cancer. It aims to see if this system can improve the management of their condition when added to standard MRI scans, with or without contrast.
What are the potential side effects?
Since MRg-NIRS is an imaging technique, it's generally non-invasive and does not involve drugs; therefore, typical drug side effects are not expected. However, discomfort from lying still during the procedure may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 18 or older.
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I have been recently diagnosed with breast cancer.
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My breast tumor is 1.5 cm or smaller, based on scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had breast cancer in the same breast before.
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I cannot have an MRI due to a pacemaker, metal implant, claustrophobia, or severe kidney issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one hour on day of mri
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one hour on day of mri for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Optical sensitivity of the MRg-NIRS platform
Secondary outcome measures
Diagnostic performance of the MRg-NIRS platform

Trial Design

1Treatment groups
Experimental Treatment
Group I: MR-guided NIRSExperimental Treatment1 Intervention
The MRg-NIRS device will be tested to see if it accommodates different breast sizes, covers the breast fully, includes the axilla, is compatible with commercial breast MRI coil and/or biopsy systems, and the signal-to-noise ratio is high enough for MRg-NIRS image reconstruction. The study team will collect MRI-derived ROI data with T1, T2 and DCE-MRI sequences from 20 women with breast abnormalities and NIRS data concurrently. The study team will also collect diffuse optical signals at 48x48 detector source positions over one side of breast at 6 wavelengths.

Find a Location

Who is running the clinical trial?

Keith D. PaulsenLead Sponsor
Dartmouth CollegeOTHER
84 Previous Clinical Trials
1,419,443 Total Patients Enrolled
5 Trials studying Breast Cancer
1,377,671 Patients Enrolled for Breast Cancer
Keith D. Paulsen, PhDPrincipal InvestigatorDartmouth College
~12 spots leftby Dec 2024
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