MRg-NIRS Imaging System Breast Cancer Trial

Breast Cancer Clinical Trial

— MRg-NIRS  

Official title:

Evaluation of the Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) Imaging System Platform in Breast Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06400563
• Other study ID #: STUDY02001582
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Keith D. Paulsen, PhD
• Phone: 603-646-2695
• Email: Keith.D.Paulsen[@]Dartmouth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 83 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Keith D. Paulsen	Dartmouth College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optical sensitivity of the MRg-NIRS platform	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	Diagnostic performance of the MRg-NIRS platform	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