Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis - Full Text View

Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

This study is currently recruiting participants.
Verified by University of California, Irvine, July 2008

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00610467

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

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment

Official Title:	Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis

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 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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:

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

Exclusion Criteria:

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.

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: Diane Huebner 949-824-6001 dkhuebne@uci.edu

Sponsors and Collaborators

University of California, Irvine

Investigators


Principal Investigator:	Min-Ying Su, PhD	University of California, Irvine

More Information

Responsible Party:	University of California, Irvine ( Min-Ying Su )
Study ID Numbers:	UCI-HS-2006-5162, NIH-CA121568
First Received:	January 12, 2008
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00610467
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases

Breast Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 15, 2008