Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

NCT ID: NCT00610467

Last Updated: 2020-04-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-01
• Study Completion Date: 2017-10-30

Brief Summary

This study investigates whether adding the optical imaging to magnetic resonance imaging can improve the diagnostic specificity of breast cancer.

Detailed Description

This proposal will investigate the performance of a combined optical-MRI imaging system in diagnosis of breast cancer. A diffuse optical tomography (DOT) imaging system will be integrated with a 3.0 T MRI scanner. It is hypothesized that the additional information measured by the combined MRI/DOT system will improve the specificity of DCE-MRI (dynamic contrast enhanced MRI) in diagnosis of breast cancer.

High resolution anatomic MRI and DCE-MRI has evolved into a standard clinical tool for detection and diagnosis of breast lesions. Due to its high sensitivity MRI is fast becoming the most popular imaging modality for screening young women who are susceptible to early development of breast cancer. Pre-operative MRI has also become a common procedure for detecting multifocal or multicentric diseases to facilitate surgical planning. However, despite its high sensitivity, MRI also detects many benign lesions. The low specificity may lead to a great anxiety to patients, and many unnecessary biopsies or over-treatment. Other adjunct imaging modality to improve specificity is greatly needed. MR spectroscopy (MRS) and DOT are two techniques that have great potential to provide complementary information.

After the study is completed, we will be able to test the hypothesis that "additional information provided by MRS and optical imaging can be used in conjunction with morphological and kinetics parameters measured by DCE-MRI to improve diagnostic accuracy of breast cancer". Furthermore, we will be able to determine among these additionally collected information, which parameter(s) are the most essential in improving diagnostic accuracy.

Although the current breast imaging modalities have achieved a high success, further improvements for the subpopulation in whom conventional imaging does not work well are in great need. Our goal is to develop an imaging technology with optimized acquisition protocol to improve diagnosis of breast cancer, particularly for young women with dense breasts who need a breast MRI examination, so that they would not be subjected to false positive findings.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Disease Group

Patients with suspicious breast diseases

Group Type: EXPERIMENTAL

Disease Group

Intervention Type: DEVICE

Participants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)

Control Group

Healthy volunteers for system testing

Group Type: EXPERIMENTAL

Control Group

Intervention Type: DEVICE

Participants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)

Interventions

Disease Group

Participants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)

Intervention Type: DEVICE

Control Group

Participants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. A female older than 21 years of age,

2. Have suspicious imaging findings suggesting a possibility of breast cancer, or biopsy-proven breast cancer.

Exclusion Criteria

1. Pregnant,

2. Unwilling to give informed consent,

3. Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,

4. Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,

5. Have received orthodontic work involving ferromagnetic materials,

6. Claustrophobic,

7. Have had allergic response to contrast agents (such as iodine or gadolinium) previously,

8. Have known history of severe renal insufficiency, asthma, allergic conditions, sickle cell anemia, chronic hemolytic anemia, and gastrointestinal disorders.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Min-Ying (Lydia) Su

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Min-Ying Su, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Center for Functional Onco-Imaging, University of California

Irvine, California, United States

Countries

United States

Other Identifiers

R21CA121568

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UCI-HS-2006-5162

Identifier Type: -

Identifier Source: org_study_id