Imagio Feasibility Multi-Reader, Multi-Case Study

Breast Cancer Clinical Trial

Official title:

Imagio Feasibility 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: NCT03708393
• Other study ID #: Reader-01
• Status: Completed
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: December 9, 2018

Study information

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

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 9, 2018
• Est. primary completion date: December 9, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	American College of Radiology	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Seno Medical Instruments Inc.	American College of Radiology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Partial Receiver Operating Characteristic (ROC) Area Under the Curve (pAUC), Cohort 1	pAUC considers only the region of the ROC space that corresponds to clinically relevant values of sensitivity defined as 95% to 99% for Imagio [IUS+OA] vs. IUS alone; averaged across 10 readers.	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)
Secondary	BiRads [Breast Imaging Reporting and Data System] Downgrades and Upgrades- Cohort 1	The cumulative effect of downgrades and upgrades for benign masses expressed as the net gain of True Negative reads	Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months
Secondary	The Negative Likelihood Ratio (NLR) for IUS vs. Imagio® (IUS+OA), Cohort 1	NLR (Imagio [IUS+OA] vs. IUS alone); averaged across 10 readers (all readers).	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)
Secondary	SenoGram Usage Cohort 1 for Imagio (IUS+OA) Only	SenoGram Utilization by number of readers using the SenoGram reported by the readers. SenoGram is not used for Imagio IUS Arm only Imagio (IUS+OA)	Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months
Secondary	SenoGram Performance	Sensitivity of SenoGram estimated from cross-validation - 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
Secondary	SenoGram Performance	Specificity of SenoGram estimated from cross-validation	Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months