Frequency Domain Optical Imaging

NCT05246735 | Completed

• 1 other identifier: STUDY00011487
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

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

  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

Study Arms (1)

MR-guided NIR

OTHER

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

Interventions

MR-guided Near Infrared optical tomography DIAGNOSTIC_TEST

MR-guided NIR

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Keith D Paulsen, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Engineering

Model Details: This is a clinical study to evaluate MR-guided near infrared absorption and fluorescence imaging

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 18, 2022
• Study Start: February 1, 2004
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share