Imagio Feasibility Multi-Reader, Multi-Case Study

Seno Medical

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Mammography; Device: Imagio (IUS+OA); Device: Imagio Ultrasound

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03708393

Reader-01

Details and patient eligibility

About

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

Full 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

Enrollment: 155 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female subjects participating in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status

Exclusion criteria

• Female subjects who did not have known clinical status in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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155 participants in 2 patient groups

Imagio IUS

Active Comparator group

Description:

Read 1 - Mammo (as available) + Imagio Ultrasound

Treatment:

Device: Imagio Ultrasound

Device: Mammography

Imagio (IUS+OA)

Experimental group

Description:

Read 2 - Mammo (as available) + (Imagio Ultrasound + OA)

Treatment:

Device: Imagio (IUS+OA)

Device: Mammography