Clinical trial NCT03708393: Imagio Feasibility Multi-Reader, Multi-Case Study
Official title: Imagio Feasibility 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
Collaborators: name: American College of Radiology
First posted: 2018-10-17
Enrollment: 155
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 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.
Primary purpose: DIAGNOSTIC

Brief summary: Controlled, blinded, multi-reader, multi-case study

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1
timeFrame: Baseline to 12 month follow-up
Secondary outcomes:
measure: Partial Receiver Operating Characteristic (ROC) Area Under the Curve (pAUC), Cohort 1
timeFrame: 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)
measure: BiRads [Breast Imaging Reporting and Data System] Downgrades and Upgrades- Cohort 1
timeFrame: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months
measure: The Negative Likelihood Ratio (NLR) for IUS vs. Imagio® (IUS+OA), Cohort 1
timeFrame: 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)
measure: SenoGram Usage Cohort 1 for Imagio (IUS+OA) Only
timeFrame: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months
measure: SenoGram Performance
timeFrame: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months
measure: SenoGram Performance
timeFrame: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: American College of Radiology
state: Pennsylvania
Study officials:
affiliation: Seno Medical
name: A. Thomas Stavros, MD
role: STUDY_DIRECTOR
References: