Frequency Domain Optical Imaging

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Suspended
• CT.gov ID: NCT05246735
• Collaborator: Dartmouth College (Other)
• Enrollment: 30
• Arm: 1
• Anticipated Duration (Months): 238.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Diagnostic Test: MR-guided Near Infrared optical tomography	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This is a clinical study to evaluate MR-guided near infrared absorption and fluorescence imagingThis is a clinical study to evaluate MR-guided near infrared absorption and fluorescence imaging
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Frequency Domain Optical Imaging of Breast Cancer
• Actual Study Start Date: Feb 1, 2004
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm

Intervention/Treatment

Other: MR-guided NIR 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.

Diagnostic Test: MR-guided Near Infrared optical tomography

Outcome Measures

Primary Outcome Measures

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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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:

2. the presence of an electronic implant, such as a pacemaker

3. the presence of a metal implant, such as an aneurysm clip

4. claustrophobia

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

6. 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:

2. the presence of an electronic implant, such as a pacemaker

3. the presence of a metal implant, such as an aneurysm clip

4. claustrophobia

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

6. Pregnancy

7. A history of allergy to iodides

8. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Dartmouth-Hitchcock Medical Center
• Dartmouth College

Investigators

• Principal Investigator: Keith D Paulsen, PhD, Dartmouth College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Keith D. Paulsen, Professor of Engineering, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT05246735
• Other Study ID Numbers: STUDY00011487
• First Posted: Feb 18, 2022
• Last Update Posted: Feb 18, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Feb 18, 2022