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Clinical Trials/NCT05246735
NCT05246735
Completed
Not Applicable

Frequency Domain Optical Imaging of Breast Cancer

Dartmouth-Hitchcock Medical Center0 sites30 target enrollmentFebruary 1, 2004
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
30
Primary Endpoint
Compare spatial localization and contrast images of breast abnormalities from MR-guided NIR absorption and fluorescence tomography to NIR absorption and fluorescence tomography alone
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This purpose of this clinical study to develop and test technology associated with near infrared (NIR) optical tomography of the breast (the use of light at NIR wavelengths to image the breast) as an adjunct to mammography and breast MRI.

Detailed Description

The purpose of this clinical study is to demonstrate the feasibility of NIR absorption and fluorescence imaging of the female breast when the method is guided by breast MRI. The hypotheses to be tested are: 1. MR-guided NIR absorption and fluorescence imaging of the breast is feasible in the setting of a clinical breast exam 2. MR-guided NIR absorption and fluorescence imaging of the breast provides spatial localization and contrast of a breast abnormality that is superior to NIR absorption and fluorescence tomography alone.

Registry
clinicaltrials.gov
Start Date
February 1, 2004
End Date
June 24, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Keith D. Paulsen

Professor of Engineering

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

Inclusion Criteria

  • Female, ≥20 years old
  • Breast size and epithelial integrity adequate to allow NIR imaging exams.
  • Ability to provide written informed consent
  • No serious associated psychiatric illnesses.

Exclusion Criteria

  • 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
  • the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
  • WOMEN WITH BREAST ABNORMALITIES
  • Female, ≥ 20 years old.
  • Breast size and epithelial integrity adequate to allow NIR imaging exams.
  • Ability to provide written informed consent.
  • No serious associated psychiatric illnesses.

Outcomes

Primary Outcomes

Compare spatial localization and contrast images of breast abnormalities from MR-guided NIR absorption and fluorescence tomography to NIR absorption and fluorescence tomography alone

Time Frame: During imaging and evaluation by a radiologist or medical technologist, up to 90 minute

Women will participate in MR-guided NIR exams which include both MR and optical contrast agents. These imaging outcomes will be compared to exams where only the MR contrast agent is used as well as to exams where no contrast agents are administered.

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