N/A N=480 Randomized Single-blind Diagnostic

Optoacoustic Images Versus Imagio® Ultrasound

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT04030104 ↗

Enrolled (actual)

480

Serious AEs

0.4%

Results posted

May 2021

Primary outcome: Primary: Gain in Specificity at Fixed 98% Sensitivity (fSp) — 38.22; 47.20 % benign+TPB masses correctly identified — p=0.0268

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Reader Study - Imagio Ultrasound (Device); Reader Study Imagio Ultrasound + Optoacoustic Imaging (Device); Mammography (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Seno Medical Instruments Inc.
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Gain in Specificity at Fixed 98% Sensitivity (fSp)	38.22; 47.20	0.0268 sig
SECONDARY Negative Likelihood Ratio (NLR)	0.053; 0.047	—
SECONDARY Positive Likelihood Ratio (PLR)	1.548; 1.959	—
SECONDARY Partial Area Under the Curve (pAUC)	0.0205; 0.0244	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04030104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.