Evaluating a new imaging system for breast cancer management
Evaluation of the Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) Imaging System Platform in Breast Cancer Patients
This study is testing a new imaging system to see if it can help women recently diagnosed with breast cancer get better information for their treatment planning compared to standard MRI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 83 Years |
| Sex | Female |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT06400563 on ClinicalTrials.gov |
What this trial studies
This trial involves 20 women with breast cancer to assess the effectiveness of an MR-guided near-infrared spectroscopy (MRg-NIRS) system, both with and without contrast, in improving clinical management alongside traditional breast MRI. The goal is to determine if MRg-NIRS can achieve diagnostic performance that is equal to or better than dynamic contrast-enhanced breast MRI alone. Participants will be women who have recently been diagnosed with breast cancer and are in pre-surgical planning.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a recent diagnosis of breast cancer and an estimated tumor size of 2.0 cm or less.
Not a fit: Patients with contraindications to MRI, such as those with electronic implants or severe claustrophobia, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the diagnostic accuracy and management of breast cancer in women.
How similar studies have performed: While this approach is innovative, similar imaging techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Keith D. Paulsen, PhD — Dartmouth College
- Study coordinator: Keith D. Paulsen, PhD
- Email: Keith.D.Paulsen@Dartmouth.edu
- Phone: 603-646-2695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.