Optoacoustic Images Versus Imagio® Ultrasound

Breast Cancer Clinical Trial

— Reader-02  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04030104
• Other study ID #: Reader-02 Study
• Status: Completed
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: November 3, 2019

Study information

• Verified date: July 2021
• Source: Seno Medical Instruments Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Imagio® Pivotal Study is intended to evaluate if the results observed in the previous Feasibility Study can be confirmed for pre-specified effectiveness endpoints. Using Intention-to-Diagnose (ITD) masses from the PIONEER Pivotal study, 480 to 840 masses are to be used for the Pivotal Study, the remaining masses will be reserved for training the SenoGram® model.

Description:

This will be a controlled, blinded, multi-reader, multi-case (MRMC) study using a sequential design. The study will include 15 readers with an additional 5 as back-up readers depending on qualifications and availability. Readers that participated in the Seno PIONEER Study (NCT01943916) or the Reader-01 Feasibility Study (NCT03708393) are not eligible to participate as readers in this Pivotal Study.

Imagio® [Ultrasound (IUS) + Optoacoustic (OA)] (IUS)(IUS+OA) training will be completed prior to any reads taking place. Read 1 will be immediately followed by Read 2 within the same read session.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: November 3, 2019
• Est. primary completion date: November 3, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• One analyzable mass per patient: BI-RADS 3 and 4a, 4b, 4c and 5 masses as declared by clinical site investigator via PIONEER study inclusion criteria and categorized as BIRADS 3, 4a, 4b 4c and 5 by conventional diagnostic ultrasound (CDU)

• Masses declared to be in the PIONEER Intention to Diagnose (ITD)/analysis population, including high risk cases per original PIONEER protocol

• Patient age, indication for study entry and available medical history

• Evaluable mammograms and OA and IUS video loops and stills for each mass

Exclusion Criteria:

• Critical missing IUS or OA still image and/or video loop views or incorrect IUS or OA stills and video loops that would preclude a case from being evaluated by readers

• Reader-02 Proficiency Test and training cases

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Reader Study - Imagio Ultrasound
Imagio ultrasound images to be reviewed as part of Reader study
• Reader Study Imagio Ultrasound + Optoacoustic Imaging
Imagio Ultrasound + Optoacoustic images to be reviewed as part of Reader study
• Mammography
Mammography as available per standard of care

Locations

Country	Name	City	State
United States	American College of Radiology Center for Research and Innovation	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Seno Medical Instruments Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gain in Specificity at Fixed 98% Sensitivity (fSp)	Primary effectiveness endpoint was the difference (gain) in specificity (fSp) at fixed 98% sensitivity for the Imagio IUS+OA relative to IUS alone, across all 15 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). fSp derived from empirical receiver operating characteristic (ROC) using endpoint interpolation.	Baseline to 12 months +/- 30 days follow-up
Secondary	Negative Likelihood Ratio (NLR)	NLR for the Imagio IUS+OA relative to IUS alone, across all 15 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). NLR = [(1-sensitivity) / specificity].	Baseline to 12 months +/- 30 days follow-up
Secondary	Positive Likelihood Ratio (PLR)	PLR for the Imagio IUS+OA relative to IUS alone, across all 15 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). PLR = [sensitivity / (1-specificity)].	Baseline to 12 months +/- 30 days follow-up
Secondary	Partial Area Under the Curve (pAUC)	pAUC considers only the region of the area under the ROC curve that corresponds to clinically relevant values of sensitivity, defined as 95% to 100%, for Imagio IUS+OA vs. IUS alone, averaged across 15 readers. Both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). A higher pAUC indicates better diagnostic accuracy.	Baseline to 12 months +/- 30 days follow-up