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Trial Title:
MRg-NIRS Imaging System Breast Cancer Trial
NCT ID:
NCT06400563
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
MRI
MRg-NIRS
Near-infrared Spectroscopy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
The study team will collect MRI-derived region of interest (ROI) data with T1, T2 and
DCE-MRI sequences from 20 women with breast abnormalities and NIRS data concurrently. The
study team will test whether the breast interface can provide optical measurements with
positional data sensitivity >1%.
The study team will conduct two interim analyses of optical sensitivity after completion
of 5-10 patient exams to decide whether the breast interface should be modified.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
MRg-NIRS
Description:
The trial tests the investigator designed and developed Magnetic Resonance-guided (MRg)
Near-infrared Spectroscopy (NIRS) imaging system for breast cancer detection. The
wearable NIRS imaging system uses 8 flex circuit strips, each with six photo-detectors
(PDs) and six source fibers, that are ready to attach to a breast radially by using an
adhesive nipple cover and breast tape.
Arm group label:
MR-guided NIRS
Other name:
MR-guided NIRS Data Collection
Summary:
This trial is a study of 20 women with breast cancer to evaluate the addition of
MR-guided (MRg) near-infrared spectroscopy (NIRS) with and without contrast, as part of a
program to improve clinical management of women receiving breast magnetic resonance
imaging (MRI).
Detailed description:
This trial is designed to determine if the MRg-NIRS system will contribute significantly
to improved clinical management of women receiving breast magnetic resonance imaging
(MRI) by achieving diagnostic performance comparable to or better than dynamic
contrast-enhanced (DCE) breast MRI alone.
The purpose of this clinical trial is to evaluate the addition of MRg-NIRS with and
without contrast in 20 women with breast cancer. The women enrolled in the trial will be
those who have a newly diagnosed breast cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Females age ≥ 18 years old
2. Participants capable of providing written informed consent
3. Women with a recent diagnosis of breast cancer.
4. Women who are in pre-surgical planning must have an estimated tumor size of 1.5 cm
or less on available imaging.
5. Women who are in pre-surgical planning must have had a breast biopsy at least 10
days prior to the MRg-NIRS exam.
Exclusion Criteria:
1. Participants with absolute or relative contraindication to MRI:
1. the presence of an electronic implant, such as a pacemaker
2. the presence of a metal implant, such as an aneurysm clip
3. claustrophobia
4. renal failure (FDA's guidance for gadolinium of a creatinine clearance less
than 30 mL/1.73 m2 BSA)
2. Pregnant women
3. Breast implants
4. Personal history of breast cancer in the ipsilateral breast.
5. Prisoners
6. Participants with visually inadequate healing from breast biopsy.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
83 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Dartmouth-Hitchcock Medical Center
Address:
City:
Lebanon
Zip:
03756
Country:
United States
Start date:
September 1, 2024
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Keith D. Paulsen
Agency class:
Other
Collaborator:
Agency:
Dartmouth College
Agency class:
Other
Source:
Dartmouth-Hitchcock Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06400563
