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NCT00754598 · ClinicalTrials.gov registry record · NA

Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography

A NA study of Breast Cancer, sponsored by Hologic.

Completed
Registry status
NA
Development phase
1,183
Enrollment target
5
Study locations

NCT00754598: Completed NA study of Breast Cancer, sponsored by Hologic.

NCT00754598 is a NA study of Breast Cancer that has completed, run by Hologic. The registered enrollment target is 1,183 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (58% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00754598, a NA study of Breast Cancer, has completed, sponsored by Hologic.

COMPLETED
Registry status
NA
Development phase
1,183 participants
Enrollment target
5
Study locations

Study Summary

This was a multi-center, prospective clinical trial in which the subject was her own control. Approximately 950-1400 female subjects were enrolled at five (5) sites in the United States. Subjects were from either a Screening population or a biopsy population and were imaged first on a conventional 2D full filed digital mammography system then on a 3D tomosynthesis system. The resulting images from the this portion of the study were then randomized into a reader study. The purpose of this clinical study was to compare the 3-D tomosynthesis system used in conjunction with a conventional 2-D digital imaging system (2-D plus 3-D images) to the conventional 2-D digital imaging system (2-D images), and to determine whether the 2-D plus 3-D images compared to the 2-D images alone would: 1. Reduce the recall rate And/or 2. Improve ROC area due to improved breast cancer detection and/or improved lesion classification.

Conditions Studied

Breast Cancer

Interventions

  • DEVICE Tomosynthesis digital mammography imaging system

Study Locations (5)

Connecticut

  • Yale New Haven Hospital - New Haven

Iowa

  • University of Iowa Medical Center - Iowa City

Massachusetts

  • Massachusetts General Hospital - Boston

New Hampshire

  • Dartmouth Hitchcock Medical Center - Lebanon

Pennsylvania

  • Magee Women's Hospital - Pittsburgh

Trial Details

FieldValue
Enrollment Target 1,183 participants
Start Date 2006-07
Est. Completion 2007-07
Phase NA

Sponsor

Hologic

21 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00754598

The ClinicalTrials.gov registry entry for NCT00754598 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,183 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (58% lower). The listed sponsor is Hologic, which has 21 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Tomosynthesis digital mammography imaging system is the first listed.

NCT00754598 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Connecticut, Iowa, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00754598 about?

NCT00754598 is a clinical study titled "Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography". This was a multi-center, prospective clinical trial in which the subject was her own control. Approximately 950-1400 female subjects were enrolled at five (5) sites in the United States. Subjects were from either a Screening population or a biopsy population and were imaged first on a conventional 2...

What is the current status of trial NCT00754598?

This trial is currently completed. It is a NA study. The enrollment target is 1,183 participants. The study started on 2006-07. Estimated completion is 2007-07.

What conditions does trial NCT00754598 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00754598?

The interventions under investigation include: Tomosynthesis digital mammography imaging system (DEVICE).

Who is sponsoring clinical trial NCT00754598?

This trial is sponsored by Hologic, which has 21 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00754598 being conducted?

This trial has 5 study locations across Connecticut, Iowa, Massachusetts, New Hampshire, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.