Clinical trial NCT00610467: Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis
Official title: Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-02-08
Enrollment: 2
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Sensitivity, Specificity, and Overall Accuracy in Differentiating Between Benign and Malignant Lesions
timeFrame: After we meet the enrollment target
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Center for Functional Onco-Imaging, University of California
state: California
Study officials:
affiliation: University of California, Irvine
name: Min-Ying Su, PhD
role: PRINCIPAL_INVESTIGATOR
References: