Frequency Domain Optical Imaging

Breast Cancer Clinical Trial

Official title:

Frequency Domain Optical Imaging of Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05246735
• Other study ID #: STUDY00011487
• Status: Completed
• Phase: N/A
• Start date: February 1, 2004
• Est. completion date: June 24, 2022

Study information

• Verified date: May 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 24, 2022
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• MR-guided Near Infrared optical tomography

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Dartmouth College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare spatial localization and contrast images of breast abnormalities from MR-guided NIR absorption and fluorescence tomography to NIR absorption and fluorescence tomography alone	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.	During imaging and evaluation by a radiologist or medical technologist, up to 90 minute