The PIONEER-01 Study of the Imagio Breast Imaging System

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

This is a prospective controlled multi-center study involving gray scale (B-mode) ultrasound vs OA/US (opto-acoustic and gray scale ultrasound) for the visualization of suspicious masses. Imagio gray scale and OA image sets will be collected on each enrolled mass and pushed to an Imaging Core Lab for processing and then to a set of Independent Readers who will read the Imagio gray-scale images vs the Imagio OA/US images.

Key facts

Study ID

NCT01943916

Run by

Seno Medical Instruments Inc.

People needed

2105

Starts

2012-12-21

Expected to finish

2015-09-09

Last updated by the study team

2023-02-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• female
• 18 years of age or older
• suspicious mass of breast, identified by a health care practitioner within the past 30 days with diagnostic methodology other than conventional ultrasound.

You may not qualify if…

• presence of a condition or impediment that may interfere with imaging.
• pregnant or lactating
• undergoing neoadjuvant therapy

Where it is running

• Radnet (Temecula) — Murrieta, California, United States
• Sally Jobe — Englewood, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Georgetown University Hospital, Department of Radiology — Washington D.C., District of Columbia, United States
• Boca Raton Regional Hospital — Boca Raton, Florida, United States
• Breast Care Atlanta — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• New York Presbyterian Hospital — New York, New York, United States
• Elizabeth Wende Breast Care — Rochester, New York, United States
• Solis Women's Health (North Carolina) — Greensboro, North Carolina, United States
• Cleveland Clinic, Breast Services DDI Clinical Research — Cleveland, Ohio, United States
• Weinstein Imaging Associates — Pittsburgh, Pennsylvania, United States
• Austin Radiological Association — Austin, Texas, United States
• MD Anderson Cancer Center, Department of Radiology and Breast Imaging — Houston, Texas, United States
• Solis Women's Health — Plano, Texas, United States
• Univ. Texas Health Science Center at San Antontio, Breast Imaging Center at the Cancer Therapy Research Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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