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Completed

NCT Number: NCT03708393

Imagio Feasibility Multi-Reader, Multi-Case Study

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

Completed

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

American College of Radiology

Philadelphia, Pennsylvania, 19103, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imagio (IUS+OA)

Device

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

Imagio Ultrasound

Device

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

Mammography

Device

Mammography images as available per standard of care

Other names: Mammo

Primary outcomes

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

    Time frame: Baseline to 12 month follow-up

    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).

Secondary outcomes

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

    Time frame: 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)

    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.

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

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

    The cumulative effect of downgrades and upgrades for benign masses expressed as the net gain of True Negative reads

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

    Time frame: 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)

    NLR (Imagio [IUS+OA] vs. IUS alone); averaged across 10 readers (all readers).

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

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

    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)

  5. SenoGram Performance

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

    Sensitivity of SenoGram estimated from cross-validation - Cohort 1

  6. SenoGram Performance

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

    Specificity of SenoGram estimated from cross-validation

Sponsors and collaborators

Lead sponsor

Seno Medical Instruments Inc.

Industry

Collaborators

  • American College of Radiology

Registry information

Official study title

Imagio Feasibility Multi-Reader, Multi-Case Study of Optoacoustic Images Versus Imagio Ultrasound to Guide Decision to Biopsy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2018
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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