MRg-NIRS Imaging System Breast Cancer Trial (MRg-NIRS)
Evaluation of the Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) Imaging System Platform in Breast Cancer Patients
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Keith D. Paulsen, PhD
- Phone Number: 603-646-2695
- Email: Keith.D.Paulsen@Dartmouth.edu
Study Contact Backup
- Name: Shudong Jiang, PhD
- Email: Shudong.Jiang@Dartmouth.edu
Study Locations
-
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Recruiting
- Dartmouth-Hitchcock Medical Center
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Contact:
- Keith D Paulsen, PhD
- Email: Keith.D.Paulsen@Dartmouth.edu
-
Sub-Investigator:
- Roberta diFlorio-Alexander, MD
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Sub-Investigator:
- Shudong Jiang, PhD
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Principal Investigator:
- Keith D Paulsen, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Females age ≥ 18 years old
- Participants capable of providing written informed consent
- Women with a recent diagnosis of breast cancer.
- Women who are in pre-surgical planning must have an estimated tumor size of 2.0 cm or less on available imaging.
- 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:
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)
- Pregnant women
- Breast implants
- Prisoners
- Participants with visually inadequate healing from breast biopsy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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. |
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Optical sensitivity of the MRg-NIRS platform
Time Frame: up to one hour on day of MRI
|
Optical data sensitivity will be measured (The sensitivity of the measurements to a given region identified by MRI, Sr, will be calculated as the sum of the log of the Jacobian times vector r.
Here, r is a logical vector that identifies points within the region of interest and J is the Jacobian, the rate of change of measurements to a change in optical properties at a location in the region identified).
|
up to one hour on day of MRI
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic performance of the MRg-NIRS platform
Time Frame: up to one hour on day of MRI
|
Diagnostic performance will be measured in terms of sensitivity, specificity and area under the receiver-operator characteristic curve (ROC).
|
up to one hour on day of MRI
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Keith D. Paulsen, PhD, Dartmouth College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY02001582
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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