Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

NCT00610467 | Terminated Results

• 2 other identifiers: UCI-HS-2006-5162R21CA121568
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity, Specificity, and Overall Accuracy in Differentiating Between Benign and Malignant Lesions

  ROC curves obtained using the regression statistical approach and the artificial neural network will be used to assess the sensitivity, specificity, and overall accuracy in differentiating between benign and malignant lesions. The ROC curves using the optimized morphological and kinetic parameters measured by DCE-MRI will be obtained first, then compared to ROC curves analyzed using the optimized DCE-MRI parameters with the addition of (1) Choline measured by MRS, (2) hemoglobin concentration and oxygen saturation measured by steady state DOT, and (3) transport rates in ICG kinetics measured by dynamic DOT

  After we meet the enrollment target

Study Arms (2)

Disease Group

EXPERIMENTAL

Patients with suspicious breast diseases

Device: Disease Group

Control Group

EXPERIMENTAL

Healthy volunteers for system testing

Device: Control Group

Interventions

Disease Group 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)

Disease Group

Control Group 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

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A female older than 21 years of age,
• Have suspicious imaging findings suggesting a possibility of breast cancer, or biopsy-proven breast cancer.

You may not qualify if:

• Pregnant,
• Unwilling to give informed consent,
• Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
• Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,
• Have received orthodontic work involving ferromagnetic materials,
• Claustrophobic,
• Have had allergic response to contrast agents (such as iodine or gadolinium) previously,
• Have known history of severe renal insufficiency, asthma, allergic conditions, sickle cell anemia, chronic hemolytic anemia, and gastrointestinal disorders.

Sponsors & Collaborators

• University of California, Irvine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Center for Functional Onco-Imaging, University of California

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Professor
• Organization: University of California Irvine

msu@uci.edu

949-824-6001

Study Officials

• Min-Ying Su, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2008
• First Posted: February 8, 2008
• Study Start: October 1, 2006
• Primary Completion: October 30, 2016
• Study Completion: October 30, 2017
• Last Updated: April 20, 2020
• Results First Posted: April 20, 2020

Record last verified: 2020-04

Locations

US (1)