RECRUITING

MRg-NIRS Imaging System Breast Cancer Trial

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Conditions

Breast CancerMRIMRg-NIRSNear-infrared Spectroscopy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Evaluation of the Magnetic Resonance-guided (MRg) Near-infrared Spectroscopy (NIRS) Imaging System Platform in Breast Cancer Patients

Quick Facts

Study Start:2024-09-23
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06400563

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 83 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Females age ≥ 18 years old
  2. 2. Participants capable of providing written informed consent
  3. 3. Women with a recent diagnosis of breast cancer.
  4. 4. Women who are in pre-surgical planning must have an estimated tumor size of 2.0 cm or less on available imaging.
  5. 5. Women who are in pre-surgical planning must have had a breast biopsy at least 10 days prior to the MRg-NIRS exam.
  1. 1. Participants with absolute or relative contraindication to MRI:
  2. 1. the presence of an electronic implant, such as a pacemaker
  3. 2. the presence of a metal implant, such as an aneurysm clip
  4. 3. claustrophobia
  5. 4. renal failure (FDA's guidance for gadolinium of a creatinine clearance less than 30 mL/1.73 m2 BSA)
  6. 2. Pregnant women
  7. 3. Breast implants
  8. 4. Prisoners
  9. 5. Participants with visually inadequate healing from breast biopsy.

Contacts and Locations

Study Contact

Keith D. Paulsen, PhD
CONTACT
603-646-2695
Keith.D.Paulsen@Dartmouth.edu
Shudong Jiang, PhD
CONTACT
Shudong.Jiang@Dartmouth.edu

Principal Investigator

Keith D. Paulsen, PhD
PRINCIPAL_INVESTIGATOR
Dartmouth College

Study Locations (Sites)

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States

Collaborators and Investigators

Sponsor: Keith D. Paulsen

  • Keith D. Paulsen, PhD, PRINCIPAL_INVESTIGATOR, Dartmouth College

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-23
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2024-09-23
Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

  • MRI
  • MRg-NIRS
  • Near-infrared Spectroscopy

Additional Relevant MeSH Terms

  • Breast Cancer