Frequency Domain Optical Imaging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-01

Study Completion Date

2022-06-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

NIR Hypoxia Imaging of Breast Tumor Response to Neoadjuvant Chemotherapy in Vivo

NCT01934114

Breast Cancer

TERMINATED

Ultrasound and Near Infrared Imaging for Breast Cancer Diagnosis and Neoadjuvant Chemotherapy Monitoring

NCT02092636

Breast Cancer

COMPLETED NA

Infrared Imaging (Breast Scan IR) for Early Breast Cancer Detection

NCT00195026

Breast Cancer

COMPLETED

Optical Tomography With Ultrasound Guidance

NCT00908609

Breast Cancer

COMPLETED

Breast Study to Determine the Ability of Non-Invasive Optical Transillumination Spectroscopy to Predict Breast Density.

NCT00188682

Breast Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

MR-guided Near Infrared optical tomography

Intervention Type DIAGNOSTIC_TEST

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MR-guided Near Infrared optical tomography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes