Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study

Completed

Conditions: Breast Cancer

Interventions: Device: DBT plus S-View
Device: FFDM Alone

Registration Number: NCT03501693

Lead Sponsor: Fujifilm Medical Systems USA, Inc.

Brief Summary: The purpose of the pivotal reader study is to assess the comparative accuracy of Fujifilm DBT plus S-View versus FFDM in the detection of breast cancer.

Detailed Description: This clinical research is a retrospective, pivotal, multi-reader, multi-case (MRMC) study with an enriched sample of 300 breast screening or diagnostic cases which were selected from the library of mammograms collected under Fujifilm protocol FMSU2013-004A (all subjects previously provided written informed consent agreeing their image data and supporting documentation could be used for future research and investigations). Approximately 18 qualified radiologists will independently perform two reads on all (approximately 300) cases. Each reader will read each case both as a FFDM read, and a DBT plus S-View read on the ASPIRE Bellus II workstation.

As its primary endpoint, this study is designed to evaluate whether the area under the receiver operating characteristic (ROC) curve (AUC) based on probability of malignancy (POM) scores and requiring correct lesion localization is statistically non-inferior for DBT plus S-View versus FFDM.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 300

Inclusion Criteria

•Female subjects participating in FMSU2013-004A protocol with known clinical status

Exclusion Criteria

•Female subjects that did not have known clinical status in FMSU2013-004A

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DBT plus S-View	DBT plus S-View	Breast images utilizing DBT plus S-View
FFDM alone	FFDM Alone	FFDM alone images

Primary Outcome Measures

Name	Time	Method
Compare Per Subject AUC: DBT Plus S-View Versus FFDM	4 weeks	Average of each radiologist reader's ROC (receiving operating characteristic curve) based on per-subject POM (probability of malignancy) scores requiring correct lesion localization. A ROC curve is a plot of Sensitivity versus 1-Specificity and is a summary of diagnostic performance of a device or clinician. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject.

Secondary Outcome Measures

Name	Time	Method
Compare Per-subject Average Recall Rate for All Non-cancer Cases for DBT Plus S-View Versus FFDM	4 weeks	Based on recall rate for all non-cancer cases for DBT plus S-View versus FFDM, using non-inferiority margin delta = 0.05. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.
Compare Per-subject Average Recall Rate for DBT Plus S-View Versus FFDM for All Cancer Cases	4 weeks	Based on recall rate for all cancer cases for DBT plus S-View versus FFDM, using non-inferiority margin delta = 0.10. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.
Compare Per-subject Average Sensitivity for DBT Plus S-View Versus FFDM	Four weeks	Based on forced BI-RADS scores requiring correct lesion localization, using non-inferiority margin delta = 0.10. The reader will first record whether there are mammographic findings and an initial BI-RADS assessment of 0, 1, or 2. If the answer to this question is "no" the reader will be asked to confirm for this case: a BI-RADS assessment category of 1 or 2, a Probability of Malignancy (POM) score following the POM guidance provided in the protocol, and recall decision of "no". If the reader answers "yes" to whether there are mammographic findings, the reader will be asked to confirm an initial BI-RADS assessment category of 0, and will then provide detailed information on each suspicious finding (up to three findings) and the decision whether or not to recall the subject, as well as overall POM score and BI-RADS assessment category.