Frequency Domain Optical Imaging

Dartmouth Health

Status: Completed

Conditions: Breast Cancer

Treatments: Diagnostic Test: MR-guided Near Infrared optical tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT05246735

STUDY00011487

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

MR-guided NIR

Other group

Description:

Women with breast abnormalities will undergo an "optical exam" (NIR) in combination with MRI where the NIR light imaging system illuminates the breast from multiple positions covering the area of interest. A total of 60 women will be evaluated: 20 with breast abnormalities receiving gadolinium (Gd) contrast enhancement, 20 with breast abnormalities receiving both Gd-contrast enhancement and indocyanine green (ICG) contrast enhancement, and 20 healthy volunteers not receiving any contrast agents.

Treatment:

Diagnostic Test: MR-guided Near Infrared optical tomography