NCT06400563 MRg-NIRS Imaging System Breast Cancer Trial
| NCT ID | NCT06400563 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Keith D. Paulsen |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-09-23 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-09-23 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Keith D. Paulsen, PhD
PRINCIPAL INVESTIGATOR
Dartmouth College
Frequently Asked Questions
Who can join the NCT06400563 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 83 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06400563 currently recruiting?
Yes, NCT06400563 is actively recruiting participants. Contact the research team at Keith.D.Paulsen@Dartmouth.edu for enrollment information.
Where is the NCT06400563 trial being conducted?
This trial is being conducted at Lebanon, United States.
Who is sponsoring the NCT06400563 clinical trial?
NCT06400563 is sponsored by Keith D. Paulsen. The principal investigator is Keith D. Paulsen, PhD at Dartmouth College. The trial plans to enroll 20 participants.
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