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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

January 12, 2008
August 2, 2011
October 2006
July 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00610467 on ClinicalTrials.gov Archive Site
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Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis
Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

This study will investigate whether adding the optical imaging to magnetic resonance imaging can improve the diagnostic specificity of breast cancer.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
Device: combined optical and MR imaging
MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
July 2013   (final data collection date for primary outcome measure)

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.
Female
21 Years to 90 Years
Yes
Contact: Min-Ying Su, PhD 949-824-6001 msu@uci.edu
United States
 
NCT00610467
UCI-HS-2006-5162, NIH-CA121568
No
Min-Ying Su, University of California, Irvine
University of California, Irvine
Not Provided
Principal Investigator: Min-Ying Su, PhD University of California, Irvine
University of California, Irvine
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP