RecruitingNot ApplicableNCT06400563

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

Sponsor

Keith D. Paulsen

Enrollment

20 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Sex: FEMALEMin Age: 18 YearsMax Age: 83 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new imaging system that combines MRI with a near-infrared light technique (MRg-NIRS) to better visualize breast cancer tumors before surgery. The goal is to see if this imaging approach can improve pre-surgical planning. **You may be eligible if...** - You are a woman aged 18 or older - You have been recently diagnosed with breast cancer - Your tumor is estimated to be 2.0 cm or smaller on existing imaging - You have had a breast biopsy at least 10 days before this study's imaging exam **You may NOT be eligible if...** - You have a pacemaker or other electronic implant - You have metal implants (such as aneurysm clips) - You have claustrophobia - You have significant kidney impairment (may affect the MRI contrast agent) - You are pregnant - You have breast implants - Your biopsy site has not healed adequately Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMRg-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.