Clinical trial NCT04030104: Optoacoustic Images Versus Imagio® Ultrasound
Official title: Imagio® Pivotal Multi-Reader, Multi-Case Study of Optoacoustic Images Versus Imagio® Ultrasound to Guide Decision to Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Seno Medical Instruments Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-23
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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 or the Reader-01 Feasibility Study are not eligible to participate as readers in this Pivotal Study.
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

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

Primary outcomes:
measure: Gain in Specificity at Fixed 98% Sensitivity (fSp)
timeFrame: Baseline to 12 months +/- 30 days follow-up
Secondary outcomes:
measure: Negative Likelihood Ratio (NLR)
timeFrame: Baseline to 12 months +/- 30 days follow-up
measure: Positive Likelihood Ratio (PLR)
timeFrame: Baseline to 12 months +/- 30 days follow-up
measure: Partial Area Under the Curve (pAUC)
timeFrame: Baseline to 12 months +/- 30 days follow-up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: American College of Radiology Center for Research and Innovation
state: Pennsylvania
Study officials:
affiliation: Seno Medical
name: Shaan Schaeffer
role: STUDY_DIRECTOR
References: