Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone

NCT02511730 | Completed Results

• 1 other identifier: FMSU2013-004E
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Breast Cancer

Keywords

Mammography

Outcome Measures

Primary Outcomes (1)

• Compare Per Subject Area Under Curve (AUC): FFDM Only vs DBT Plus FFDM

  Breast AUC performance metrics to determine if FFDM plus DBT improved cancer detection rate, requiring correct lesion localization. Statistician to estimate AUCs for each reader in each review condition (FFDM read in conjunction with FFDM plus DBT read) based on their Probability of Malignancy (POM) scores. POM scores will require correct lesion localization, such that in a case with cancer if the reader recorded one or more findings in the case but none of them are determined by the truther to match the location(s) of any proven malignancies, a POM score of 0 will be assigned to the case. Statistician to provide graphical representations of each reader's ROC curve for each review condition. For each reader the difference between the AUC for the FFDM read in conjunction with the FFDM plus DBT will be presented. Statistician to perform MRMC comparison of AUC's between FFDM read in conjunction with FFDM plus DBT using the MRMC method of Dorfman, Berbaum \& Metz (1992).

  1 month

Study Arms (2)

FFDM Plus DBT

EXPERIMENTAL

Breast Images with FFDM and DBT

Device: FFDM Plus DBT

FFDM Alone

ACTIVE COMPARATOR

Breast Images with FFDM alone

Device: FFDM

Interventions

FFDM Plus DBT DEVICE

FujiFilm Aspire Cristalle System

FFDM Plus DBT

FFDM DEVICE

FujiFilm Aspire Cristalle System

FFDM Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects participating in FMSU004A protocol with known clinical status

You may not qualify if:

• Subjects with unknown clinical status not participating in FMSU004A protocol.

Sponsors & Collaborators

• Fujifilm Medical Systems USA, Inc.: lead

Study Sites (4)

Scottsdale Medical Imaging, Limited (SMIL)

Scottsdale, Arizona, 85258, United States

Location

Elizabeth Wende Breast Care, LLC (EWBC)

Rochester, New York, 14620, United States

Location

University of North Carolina - at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Randy Vader
• Organization: Fujifilm Medical Systems USA, Inc.

randy.vader@fujifilm.com

360-356-6821

Study Officials

• Robert M Uzenoff

  Fujifilm Medical Systems USA, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 30, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 21, 2023
• Results First Posted: June 4, 2020

Record last verified: 2023-09

Locations

US (4)