Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing

NCT03586583 | Completed Results FDA Device

• 1 other identifier: FMSU2017-003
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the feature comparison study is to evaluate general mammographic features in images of the same breast when reconstructed with modified (ISR and DVIIm) processing as compared to the original processing (FBP with EDR and MFP).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of ISR (Modified Processing) to FBP (Original Processing)

  For each reader, the cases judged as non-inferior with modified processing will be calculated for each feature and each view. Non-inferiority will be defined as a score of equivalence between modified and original or a score indicating the modified image processing is superior. Readers compared several general mammographic features using the following 5-point scale: negative 2 (left image much superior) negative 1 (left image somewhat superior) 0 (left and right images are equivalent) positive 1 (right image somewhat superior) positive 2 (right image much superior)

  1 day reading session

Study Arms (2)

FBP (old processing)

Filtered back projection; old processing.

Device: FBP

ISR (new processing)

Iterative super resolution; new processing.

Device: ISR

Interventions

FBP DEVICE

Old processing

FBP (old processing)

ISR DEVICE

New processing

ISR (new processing)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

600

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fujifilm Medical Systems USA, Inc.: lead
• International HealthCare, LLC: collaborator

Study Sites (1)

International HealthCare, LLC

Norwalk, Connecticut, 06851, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

randy.vader@fujifilm.com

360-356-6821

Study Officials

• Susan Crennan

  Fujifilm Medical Systems USA, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 13, 2018
• Study Start: June 30, 2018
• Primary Completion: June 30, 2018
• Study Completion: November 19, 2018
• Last Updated: September 21, 2023
• Results First Posted: May 20, 2020

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)