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Completed

NCT Number: NCT02692209

A Multi-Reader Multi-Case Pivotal Trial

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.

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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

Observational

Primary location

Scottsdale Medical Imaging, Ltd, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Eligible subjects under protocol FMSU2013-004A, defined as female subjects with known true clinical status and with complete FFDM and DBT examinations, in which there is sufficient anatomical coverage, sufficient contrast, and no significant motion or other artifacts, as determined by the image-acquisition sites.
  • Meet none of the exclusion criteria under protocol FMSU2013-004A.

Exclusion criteria

  • Subjects who are in violation of protocol FMSU2013-004A.
  • Subjects who meet exclusion criteria under protocol FMSU2013-004A.
  • Subjects with unknown clinical status.
  • Any subject whose positive mammogram was not read during the truthing process (see section 8) will not be considered for the pivotal MRMC reader study.

Treatment and study plan

FFDM Plus DBT

Device

FFDM + DBT Images

FujiFilm Aspire Cristalle System

FFDM alone

Device

FFDM Alone Images

Primary outcomes

  1. 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.

    Time frame: 1 month

    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.

Sponsors and collaborators

Lead sponsor

Fujifilm Medical Systems USA, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 25, 2016
Registry last updated
Jul 7, 2020

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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