Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Reader performance when SoftVue automated breast ultrasound (SV) and digital screening mammography (DM) are combined, compared to screening mammography alone.

Reading of Automated Breast Ultrasound in conjunction with Screening Mammography

Yulei Jiang, Ph.D

The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma.

This reader study will include up to 32 radiologist readers and a sample of 140 breast screening cases that were selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phase B. The reader study image case set will be enriched with cancer cases.

Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)

A Retrospective, Observational, Case-controlled, Multi-reader, Multi-case, Receiver Operating Characteristic (ROC) Study of Reader Performance When SoftVue Automated Breast Ultrasound (SV) and Digital Screening Mammography (DM) Are Combined, Compared to Screening Mammography Alone, in Asymptomatic Women With Heterogeneous or Extremely Dense Breast Parenchyma

True Positive Rate and True Negative Rate

University of Chicago

Boston Biomedical Associates

Delphinus Medical Technologies, Inc.

Mary Ellen Giger, Ph.D

The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma.

This reader study will include approximately 32 radiologist readers and a sample of approximately 200 breast screening cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phases B, C, and D. The reader study image case set will be enriched with cancer cases.

Delphinus SoftVue™ ROC Reader Study

A Retrospective, Observational, Case-controlled, Multi-reader, Multi-case, Receiver Operating Characteristic (ROC) Study of Reader Performance When SoftVue Automated Breast Ultrasound (SV) and Digital Screening Mammography (DM) Are Combined, Compared to Screening Mammography Alone, in Asymptomatic Women With Heterogeneous or Extremely Dense Breast Parenchyma.

Reed Technical Associates, LLC

Breast Diseases

Skin Diseases

The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. This includes obtaining information that can be used to properly plan, design, and power future ROC reader studies.

This reader study will include a minimum of 6 radiologist readers and an enriched sample of at least 100 breast screening or diagnostic cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839). The reader study image case set will be enriched with cancer cases.

A Retrospective, Observational, Case-Controlled, Multi-Reader, Multi-Case, Receiver Operating Characteristic (ROC) Study of Reader Performance When SoftVue Automated Breast Ultrasound (SV) and Digital Screening Mammography (DM) Are Combined, Compared to Screening Mammography Alone, in Asymptomatic Women With Heterogeneous or Extremely Dense Breast Parenchyma.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)	NCT04260620	Breast Cancer D... Dense Breast Pa... Benign Breast F... Normal Breast S... Abnormal Breast...	Reading of Auto...	-	Delphinus Medical Technologies, Inc.
Delphinus SoftVue™ ROC Reader Study	NCT03972605	Breast Cancer D... Dense Breast Pa... Benign Breast F... Normal Breast S... Abnormal Breast...	Reading of Auto...	-	Delphinus Medical Technologies, Inc.
Delphinus SoftVue™ ROC Reader Study	NCT03698942	Breast Cancer Breast Neoplasm...	Reading of Auto...	-	Delphinus Medical Technologies, Inc.

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