NCT03708393

Imagio Feasibility Multi-Reader, Multi-Case Study

Imagio Feasibility Multi-Reader, Multi-Case Study of Optoacoustic Images Versus Imagio Ultrasound to Guide Decision to Biopsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Seno Medical Instruments Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Controlled, blinded, multi-reader, multi-case study

Detailed description

The Imagio Feasibility Reader Study-01 Study is intended to evaluate if a subsequent pivotal study can be implemented to test prospective hypotheses for pre-specified effectiveness endpoints with an acceptable sample size. The Feasibility Study will be based on ITD masses from the PIONEER (NCT01943916) Pivotal study to simultaneously reflect the distributions with and without mammograms as well as site CDU BI-RADS scores within benign and malignant masses as strata. The study population will be split into 3 cohorts - Cohort 1, the 120 patient ITD Population used to run the primary/ secondary analyses. Cohort 2, 30 patients used to run exploratory analyses on false negative rate and Cohort 3, 5 patients used to run exploratory analyses on specific mass types

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Imagio (IUS+OA)	The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study
DEVICE	Imagio Ultrasound	Imagio ultrasound images to be reviewed as part of the reader study
DEVICE	Mammography	Mammography images as available per standard of care

Timeline

• Start date: 2018-11-13
• Primary completion: 2018-12-09
• Completion: 2018-12-09
• First posted: 2018-10-17
• Last updated: 2021-08-06
• Results posted: 2021-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study