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Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

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ClinicalTrials.gov Identifier: NCT00610467
Recruitment Status : Terminated
First Posted : February 8, 2008
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Min-Ying (Lydia) Su, University of California, Irvine

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

Condition or disease Intervention/treatment
Breast Cancer Device: combined optical and MR imaging

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis
Study Start Date : October 2006
Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Device: combined optical and MR imaging
    MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)


Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610467


Locations
United States, California
Center for Functional Onco-Imaging, University of California
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Min-Ying Su, PhD University of California, Irvine

Responsible Party: Min-Ying (Lydia) Su, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00610467     History of Changes
Other Study ID Numbers: UCI-HS-2006-5162
NIH-CA121568
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016

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