MRg-NIRS Imaging System Breast Cancer Trial
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).
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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). |
| Who can participate | 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 vi |
| Ages | 18 Years to 83 Years |
| Sex | Female |
| Lead sponsor | Keith D. Paulsen |
| Locations | Lebanon, New Hampshire, United States |
| Start date | 2024-09-23 |
| NCT ID | NCT06400563 |
| Official listing | https://clinicaltrials.gov/study/NCT06400563 |