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Completed

NCT Number: NCT05246735

Frequency Domain Optical Imaging

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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:

  • MR-guided NIR absorption and fluorescence imaging of the breast is feasible in the setting of a clinical breast exam
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

HEALTHY VOLUNTEERS

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.
  • Pregnancy

WOMEN WITH BREAST ABNORMALITIES

Inclusion:

  • 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.
  • A recent screening mammogram that questions the presence of an abnormality, thus requiring further mammographic examination.

Exclusion:

  • 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.
  • Pregnancy
  • A history of allergy to iodides
  • A GFR < 30 ml/min as determined by blood test on the day of NIR/MR imaging, or from lab results within 3 months of NIR/MR imaging.

Treatment and study plan

MR-guided Near Infrared optical tomography

Diagnostic Test

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Dartmouth College

Registry information

Official study title

Frequency Domain Optical Imaging of Breast Cancer

Important dates

Study start
2004
Primary completion
2022
Study completion
2022
First posted
Feb 18, 2022
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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