Clinical trial NCT05246735: Frequency Domain Optical Imaging
Official title: Frequency Domain Optical Imaging of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
First posted: 2022-02-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a clinical study to evaluate MR-guided near infrared absorption and fluorescence imaging
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: HEALTHY VOLUNTEERS

Inclusion Criteria:

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

Exclusion Criteria:

1. 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. the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
2. Pregnancy

WOMEN WITH BREAST ABNORMALITIES

Inclusion:

1. Female, ≥ 20 years old.
2. Breast size and epithelial integrity adequate to allow NIR imaging exams.
3. Ability to provide written informed consent.
4. No serious associated psychiatric illnesses.
5. A recent screening mammogram that questions the presence of an abnormality, thus requiring further mammographic examination.

Exclusion:

1. 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. the presence of other contraindication(s), as determined by the MRI technologists and radiologists.
2. Pregnancy
3. A history of allergy to iodides
4. 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.

Primary outcomes:
measure: Compare spatial localization and contrast images of breast abnormalities from MR-guided NIR absorption and fluorescence tomography to NIR absorption and fluorescence tomography alone
timeFrame: During imaging and evaluation by a radiologist or medical technologist, up to 90 minute
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dartmouth College
name: Keith D Paulsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: