MRg-NIRS Imaging System Breast Cancer Trial
Recruiting · NCT06400563 · Interventional (participants receive a specific treatment) · Lead sponsor: Keith D. Paulsen
View the official record on ClinicalTrials.gov →Interventions studied
MRg-NIRS
What this trial is about
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 take part
Age range
18 Years to 83 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed across 1 US state.
- Dartmouth-Hitchcock Medical Center - Lebanon, New Hampshire, United States