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Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

This study is currently recruiting participants.
Verified August 2011 by University of California, Irvine
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00610467
First received: January 12, 2008
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention
Breast Cancer
 Device: combined optical and MR imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • To prove that combined optical/MRI imaging system can enhance the diagnostic specificity compared to that using MRI alone. [ Time Frame: at completion of this study ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2006
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: combined optical and MR imaging
    MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)
  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610467

Contacts
Contact: Min-Ying Su, PhD 949-824-6001 msu@uci.edu

Locations
United States, California
Center for Functional Onco-Imaging, University of California Recruiting
Irvine, California, United States, 92697
Contact: Jodi MacGregor     949-824-6001     jmacgreg@uci.edu    
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Min-Ying Su, PhD University of California, Irvine
  More Information

No publications provided

Responsible Party: Min-Ying Su, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00610467     History of Changes
Other Study ID Numbers: UCI-HS-2006-5162, NIH-CA121568
Study First Received: January 12, 2008
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013