Evaluating a new imaging system for breast cancer management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.