Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

DBT plus S-View

FFDM Alone

Robert M Uzenoff

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.

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.

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

A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study

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.

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.

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.

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.

Fujifilm Medical Systems USA, Inc.

There were no AE's expected for this study, as it was a radiologist reader study utilizing retrospective imaging. No study subjects were on-site for this retrospective review. No Adverse Events to report.

Breast images utilizing DBT plus S-View

DBT plus S-View: DBT plus S-View images

DBT Plus S-View

FFDM alone images

FFDM Alone: FFDM alone images

300 retrospectively collected breast images to be reviewed (both DBT plus S-View and FFDM alone for all 300 images)

DBT Plus S-View and FFDM Alone

Particant Age Mean

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Randy Vader

Retrospective images used from Fujifilm protocol FMSU2013-004A. All readers read the same 300 images in their own randomized order during 2 sessions (they read half of each modality at each session which were separated by a 4 week washout period).

Compare Per Subject AUC: DBT Plus S-View Versus FFDM

240 non-cancer cases evaluated out of 300 total cases acquired under Fujifilm protocol FMSU2013-004A.

Compare Per-subject Average Recall Rate for All Non-cancer Cases for DBT Plus S-View Versus FFDM

60 cancer cases were read (out of the total of 300 cases) from the previously acquired Fujifilm FMSU2013-004A acquisition study.

Compare Per-subject Average Recall Rate for DBT Plus S-View Versus FFDM for All Cancer Cases

Sensitivity was analyzed in 60 cancer cases.

Compare Per-subject Average Sensitivity for DBT Plus S-View Versus FFDM

Readers will read half of the DBT plus S-View images followed by half of the FFDM only images at each of 2 sessions. There was a four week memory washout period between the 2 sessions.

DBT Plus S-View, Then FFDM Only

Readers will read half of the FFDM images followed by half of the DBT plus S-Viewonly images at each of 2 sessions. There was a four week memory washout period between the 2 sessions.

FFDM Only, Then DBT Plus S-View

First Reading Session

4 Week Memory Washout Period

Second Reading Session

FFDM alone

Laurie L. Fajardo, M.D.

The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.

This clinical research is a retrospective, pilot, multi-reader, multi-case (MRMC) study with an enriched sample of 100 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 6 qualified radiologists will independently perform two reads on all (approximately 100) cases. Each reader will read each case both as a FFDM (Full Field Digital Mammography) read, and a DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) read on the ASPIRE Bellus II workstation.

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

A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pilot Study

Compare per subject average area under the ROC curve (AUC) for DBT (Digital Breast Tomosynthesis) plus S-View (Synthesized View) versus FFDM (Full Field Digital Mammography), based on per-subject POM (probability of malignancy) scores and requiring correct lesion localization. The primary endpoint was non-inferior per-subject average AUC. Statistician estimated AUCs for each reader in each review condition (FFDM, DBT plus S-View) based on per-subject POM scores requiring correct lesion localization. Statistician also calculated for each reader the non-parametric (trapezoidal) AUC for the FFDM read, the DBT plus S-View read, and the difference between them. These AUC's, differences between them, and the associated variance-covariance matrix were obtained using the method of DeLong, et al.

Breast images using FFDM alone only

FFDM alone: FFDM alone images

Age, Continuous

The primary endpoint for this study was a non-inferior per-subject average area under the receiver operating characteristic (ROC) curve (AUC) requiring correct lesion localization for DBT (digital breast tomosynthesis) plus S-View (synthesized view) versus FFDM (full field digital mammography). AUCs for each reader were estimated in each review condition based on per-subject probability of malignancy (POM) scores requiring correct lesion localization.

Retrospective images used from Fujifilm protocol FMSU2013-004A. All readers read the same 100 images in their own randomized order during 2 sessions (they read half of each modality at each session which were separated by a 4 week washout period).

Compare Per Subject Average Area Under the ROC (Receiver Operating Characteristic) Curve (AUC)

FFDM Plus DBT images are being evaluated as compared to FFDM alone

Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT

FFDM + DBT Images

FujiFilm Aspire Cristalle System

FFDM Plus DBT

The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.

The safety and effectiveness of FFDM + DBT are both linked to the ability of radiologists interpreting FFDM + DBT images to accurately diagnose breast cancer. Each study endpoint therefore addresses both safety and effectiveness.

A Multi-Reader Multi-Case Pivotal Trial

A Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of the Fujifilm FFDM Plus DBT Versus FFDM Alone in the Detection of Breast Cancer

The study will be considered to have successfully demonstrated safety and effectiveness of the Fujifilm Aspire Cristalle: FFDM +DBT system if the per-subject average AUC for FFDM+DBT is statistically significantly superior to the average AUC for FFDM alone at the alpha = 0.05 significance level. Per-subject BI-RADS, POM and recall scores requiring correct lesion localization were derived. The general principle is that even at the subject level, credit was only given for identifying a subject with cancer if the reader marked findings in at least one location with cancer. When computing sensitivity and specificity based on BI-RADS, a score of 4 or 5 constituted a positive test result.

FFDM Plus DBT images are being evaluated as compared to FFDM alone

FFDM Plus DBT: FFDM + DBT Images

FujiFilm Aspire Cristalle System

Fujifilm FFDM alone images are being evaluated as compared to FFDM + DBT

FFDM Alone: FFDM Alone Images

Full Field Digital Mammography

There were 298 study participants in total who had their images reviewed by 28 radiologist readers. Images were acquired under acquisition study FMSU2013-004A.

All 298 Cases/Study Participants

Full Field Digital Mammography (FFDM)

Twenty-eight qualified radiologists independently performed reads on all 298 cases. Each radiologist reader read each case sequentially, first as a FFDM read, and then FFDM + DBT read, all on the Aspire Bellus workstation.

Correct Lesion Localization: Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) for FFDM + DBT Versus FFDM Alone Based on Probability of Malignancy (POM) Scores and Requiring Correct Lesion Localization.

FFDM images are being evaluated as compared to FFDM Plus DBT

FujiFilm Aspire Cristalle System

This is a sequential read, each reader read the case as a FFDM read followed by a FFDM plus DBT read

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study	NCT03501693	Breast Cancer	DBT plus S-View FFDM Alone	18 Years -	Fujifilm Medical Systems USA, Inc.
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer	NCT03491917	Breast Cancer	DBT plus S-View FFDM alone	18 Years -	Fujifilm Medical Systems USA, Inc.
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer	NCT03491917	Breast Cancer	DBT plus S-View FFDM alone	18 Years -	Fujifilm Medical Systems USA, Inc.
A Multi-Reader Multi-Case Pivotal Trial	NCT02692209	Breast Cancer	FFDM Plus DBT FFDM Alone	18 Years -	Fujifilm Medical Systems USA, Inc.

Spots Global Cancer Trial Database for ffdm alone

Every month we try and update this database with for ffdm alone cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for ffdm alone

Every month we try and update this database with for ffdm alone cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ffdm alone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.