RecruitingNot Applicable

MRg-NIRS Imaging System Breast Cancer Trial

United States20 participantsStarted 2024-11-25

Plain-language 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

Age range

18 Years – 83 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Optical sensitivity of the MRg-NIRS platform

Timeframe: up to one hour on day of MRI

Trial details

NCT IDNCT06400563

SponsorKeith D. Paulsen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-07-01

Contact for this trial

Keith D. Paulsen, PhD

603-646-2695 Keith.D.Paulsen@Dartmouth.edu

View on ClinicalTrials.gov More Breast Cancer trials