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Recruiting NCT06400563

MRg-NIRS Imaging System Breast Cancer Trial

Conditions: Breast Cancer

Sex: Female
Ages: 18 Years – 83 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Keith D. Paulsen

Location: Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06400563). StuddyBuddy aggregates publicly available trial information.