MRg-NIRS Imaging System Breast Cancer Trial
Evaluation of the Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) Imaging System Platform in Breast Cancer Patients
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 83 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study will test an imaging system that adds near-infrared light measurements to breast MRI scans. It will test the system with and without contrast, a dye used for imaging, in 20 women with breast cancer. The goal is to help improve care for women getting breast MRI scans.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 18 or older.
- Able to give written consent to join the study.
- Recently diagnosed with breast cancer.
- If planning surgery, the tumor must measure 2 centimeters or less on available scans.
- If planning surgery, you must have had a breast biopsy (a tissue sample taken) at least 10 days before the study scan.
Who can't join
- An electronic implant, such as a pacemaker.
- A metal implant, such as a clip used to treat a bulging blood vessel.
- Claustrophobia (fear of tight or closed spaces).
- Kidney failure, with a kidney filtering rate below the study's stated limit.
- Pregnant.
- Breast implants.
- Prisoners.
- A breast biopsy site that does not look well enough healed.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
NH
- Dartmouth-Hitchcock Medical Center · Lebanon, NH 03756Keith D Paulsen, PhD · Study contact · Keith.D.Paulsen@Dartmouth.eduRoberta diFlorio-Alexander, MD · Sub-investigatorShudong Jiang, PhD · Sub-investigatorKeith D Paulsen, PhD · Principal investigatorMore trials in Lebanon