MRg-NIRS Imaging System Breast Cancer Trial
Evaluation of the Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) Imaging System Platform in Breast Cancer Patients
Keith D. Paulsen
20 participants
Sep 23, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria5
- 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 Criteria9
- 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.
Interventions
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(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06400563