Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System

Status unconfirmed

Conditions studied: Breast Cancer

In brief

The primary study endpoint -SoftScan adjunctive accuracy- will be used to test the hypothesis that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic accuracy that is significantly better than x-ray mammography alone.

Key facts

Study ID

NCT00267449

Run by

ART Advanced Research Technologies Inc.

People needed

950

Starts

2005-11-01

Last updated by the study team

2007-09-11

Who can join

Age: 20 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women between the ages of 20 and 80 years of age, who are either healthy or who are scheduled to undergo a tissue biopsy of surgical excision of a suspicious breast lesion for histopathologic diagnosis.

You may not qualify if…

• For the Healthy Volunteers Population,
• subjects with a history of minor breast procedures involving either breast;
• subjects with a history of major breast procedures involving either breast;
• subjects with a history of significant acute breast abnormalities involving either breast; and
• subjects with a history of significant chronic breast abnormalities involving either breast; and
• For Referred For Biopsy Population,
• subjects with a history of minor breast procedures involving either breast that were performed within 6 months prior to enrollment or which have not completed active healing at the time of enrollment;
• subjects with a history of major breast procedures involving either breast;
• subjects with a history of significant acute breast abnormalities involving either breast which have not completed active healing or resolution within 6 months prior to enrollment; and
• subjects with a history of significant chronic breast abnormalities involving either breast.

Where it is running

• University of California-San Diego - Rebecca and John Moores Cancer Center — La Jolla, California, United States (enrolling)
• Stanford University - Stanford Breast Imaging Center — Stanford, California, United States (enrolling)
• Martin Memorial Health Systems, Stuart - Robert & Carol Weissman Cancer Center — Stuart, Florida, United States (enrolling)
• CAMIS - Central Alberta Medical Imaging Services — Red Deer, Alberta, Canada (enrolling)
• University Health Network (UNH) - Princess Margaret Hospital — Toronto, Ontario, Canada (enrolling)
• MUHC- McGill University Health Center — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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