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NCT02511730 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Fujifilm Medical Systems USA.

Completed
Registry status
NA
Development phase
100
Enrollment target

NCT02511730: Completed NA study, sponsored by Fujifilm Medical Systems USA.

NCT02511730 is a NA study that has completed, run by Fujifilm Medical Systems USA. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT02511730, a NA study, has completed, sponsored by Fujifilm Medical Systems USA.

COMPLETED
Registry status
NA
Development phase
100 participants
Enrollment target

Study Summary

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

Primary Outcome

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

Interventions

  • DEVICE FFDM Plus DBT
  • DEVICE FFDM

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2015-06
Est. Completion 2015-08
Phase NA
Fujifilm Medical Systems USA

13 total trials

What the finished NCT02511730 record still lists

NCT02511730 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 2 interventions - of which FFDM Plus DBT is the first listed.

NCT02511730 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02511730 about?

NCT02511730 is a clinical study titled "Pilot Mammography Reader Study to Assess Breast Cancer Detection in FFDM Plus DBT Versus FFDM Alone". The purpose of this pilot is to provide credible performance estimate information in order to conduct subsequent reader studies.

What is the current status of trial NCT02511730?

This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2015-06. Estimated completion is 2015-08.

What interventions are being tested in trial NCT02511730?

The interventions under investigation include: FFDM Plus DBT (DEVICE), FFDM (DEVICE).

Who is sponsoring clinical trial NCT02511730?

This trial is sponsored by Fujifilm Medical Systems USA, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02511730's enrollment target sits among peer trials

100 840th of 2000 higher than 1,081 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02511730, the US trial registry maintained by the National Library of Medicine. NCT02511730 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.