Optoacoustic Images Versus Imagio® Ultrasound

NCT04030104 | Completed Results FDA Device

• 1 other identifier: Reader-02 Study
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Negative Likelihood Ratio (NLR)

  Baseline to 12 months +/- 30 days follow-up

• Positive Likelihood Ratio (PLR)

  Baseline to 12 months +/- 30 days follow-up

• Partial Area Under the Curve (pAUC)

  Baseline to 12 months +/- 30 days follow-up

Study Arms (2)

Imagio IUS

ACTIVE COMPARATOR

Read 1 (Control): History + Mammogram (if available) + IUS (Imagio Ultrasound) stills and videos provided), IUS Probability of Malignancy (POM) and Breast Imaging Reporting and Data System (BI-RADS) scored and the data form then locked.

Device: Reader Study - Imagio Ultrasound; Device: Mammography

Imagio (IUS+OA)

EXPERIMENTAL

Read 2 (Test): History + Mammogram (if available) + IUS (stills and videos provided), and Imagio (IUS+OA) (stills and videos provided). Imagio (IUS+OA) POM and Breast Imaging Reporting and Data System (BI-RADS) assigned after viewing the SenoGram® output. The dataform is locked.

Device: Reader Study Imagio Ultrasound + Optoacoustic Imaging; Device: Mammography

Interventions

Reader Study - Imagio Ultrasound DEVICE

Imagio ultrasound images to be reviewed as part of Reader study

Imagio IUS

Reader Study Imagio Ultrasound + Optoacoustic Imaging DEVICE

Imagio Ultrasound + Optoacoustic images to be reviewed as part of Reader study

Imagio (IUS+OA)

Mammography DEVICE

Mammography as available per standard of care

Also known as: Mammo

Imagio (IUS+OA); Imagio IUS

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Images from female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seno Medical Instruments Inc.: lead

Study Sites (1)

American College of Radiology Center for Research and Innovation

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Vice President of Clinical Operations
• Organization: Seno Medical Instruments, Inc.

sschaeffer@senomedical.com

210-615-6501

Study Officials

• Shaan Schaeffer

  Seno Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Readers will not be provided with information regarding the initial patient diagnosis
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 or the Reader-01 Feasibility Study are not eligible to participate as readers in this Pivotal Study.

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: July 23, 2019
• Study Start: July 30, 2019
• Primary Completion: November 3, 2019
• Study Completion: November 3, 2019
• Last Updated: July 12, 2021
• Results First Posted: May 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)