Imagio Feasibility Multi-Reader, Multi-Case Study

NCT03708393 | Completed Results FDA Device

• 1 other identifier: Reader-01
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1

  Primary effectiveness endpoint was the specificity of Imagio \[IUS+OA\] compared to IUS alone at fixed 95-99% sensitivity (fSp) interpolated from the area under the curve (AUC) of receiver operating characteristic (ROC) curves, averaged across all 10 independent readers. Both imaging modalities (IUS alone and IUS+OA) were read for 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).

  Baseline to 12 month follow-up

Secondary Outcomes (6)

• Partial Receiver Operating Characteristic (ROC) Area Under the Curve (pAUC), Cohort 1

  Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months (≥11 months)

• BiRads [Breast Imaging Reporting and Data System] Downgrades and Upgrades- Cohort 1

  Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months

• The Negative Likelihood Ratio (NLR) for IUS vs. Imagio® (IUS+OA), Cohort 1

  Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months (≥11 months)

• SenoGram Usage Cohort 1 for Imagio (IUS+OA) Only

  Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months

• SenoGram Performance

  Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months

Study Arms (2)

Imagio IUS

ACTIVE COMPARATOR

Read 1 - Mammo (as available) + Imagio Ultrasound

Device: Imagio Ultrasound; Device: Mammography

Imagio (IUS+OA)

EXPERIMENTAL

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

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

Interventions

Imagio (IUS+OA) DEVICE

The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study

Imagio (IUS+OA)

Imagio Ultrasound DEVICE

Imagio ultrasound images to be reviewed as part of the reader study

Imagio IUS

Mammography DEVICE

Mammography images as available per standard of care

Also known as: Mammo

Imagio (IUS+OA); Imagio IUS

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seno Medical Instruments Inc.: lead
• American College of Radiology: collaborator

Study Sites (1)

American College of Radiology

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: Shaan Schaeffer VP of Clinical Operations
• Organization: Seno Medical

sschaeffer@senomedical.com

610-698-3259

Study Officials

• A. Thomas Stavros, MD

  Seno Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent Readers blinded to mass 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 5-12 independent readers depending on qualifications and availability. Imagio (IUS+OA) Training to be completed prior to any reads taking place. Read 1 is immediately followed by Read 2 within the same read session. Read 1 (Control): Mammogram (if available) + History + IUS (stills and videos provided), IUS Probability of Malignancy (POM) and BI-RADS scored and the data form locked. Read 2 (Test): Mammogram (if available) + History + IUS (stills and videos provided), and Imagio (IUS+OA) (stills and videos provided). An interim IUS POM and BI-RADS is recorded as well as a combined Imagio (IUS+OA) POM and BIRADS Pre and Post SenoGram on separate data forms.

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 17, 2018
• Study Start: November 13, 2018
• Primary Completion: December 9, 2018
• Study Completion: December 9, 2018
• Last Updated: August 6, 2021
• Results First Posted: August 6, 2021

Record last verified: 2021-07

Locations

US (1)