CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,105 enrolled
Drug / intervention
Imagio OA/US (US and OA/US) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01943916
NCT01943916N/ACompleted
CompareCT.gov

A Study of Imaging With Opto-acoustics to Diagnose Breast Masses Detected by Mammography and/or Diagnostic Ultrasound: A New Evaluation Tool for Radiologists

Seno Medical Instruments Inc.·interventional·Posted Sep 17, 2013·Updated Feb 8, 2023

In Brief

A clinical study evaluating Imagio OA/US (US and OA/US) and Imagio gray scale ultrasound for Breast Cancer. Completed, enrolled 2,105 participants across 16 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 17, 2013
Enrollment StartDec 21, 2012
Primary CompletionSep 9, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.8 years ago

Interventions

Imagio OA/US (US and OA/US)device

opto-acoustic plus gray scale ultrasound

Imagio gray scale ultrasounddevice

gray scale ultrasound alone