Clinical trial NCT06400563: MRg-NIRS Imaging System Breast Cancer Trial
Official title: Evaluation of the Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) Imaging System Platform in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: MRI
MRg-NIRS
Near-infrared Spectroscopy
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
First posted: 2024-05-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.

The breast interface is a non-significant risk device.
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

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 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. 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. Prisoners
5. Participants with visually inadequate healing from breast biopsy.

Primary outcomes:
measure: Optical sensitivity of the MRg-NIRS platform
timeFrame: up to one hour on day of MRI
Secondary outcomes:
measure: Diagnostic performance of the MRg-NIRS platform
timeFrame: up to one hour on day of MRI
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Keith D. Paulsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: