Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-09-23
2027-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
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.
The breast interface is a non-significant risk device.
DEVICE_FEASIBILITY
NONE
Study Groups
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MR-guided NIRS
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.
MRg-NIRS
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.
Interventions
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MRg-NIRS
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 2.0 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. 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. Prisoners
5. Participants with visually inadequate healing from breast biopsy.
18 Years
83 Years
FEMALE
No
Sponsors
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Dartmouth College
OTHER
Keith D. Paulsen
OTHER
Responsible Party
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Keith D. Paulsen
Professor of Engineering
Principal Investigators
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Keith D. Paulsen, PhD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth College
Locations
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY02001582
Identifier Type: -
Identifier Source: org_study_id
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