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COMPLETED NA

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

NCT00754598 · View on ClinicalTrials.gov ↗

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

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

7 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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,183 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hologic, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00754598 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Connecticut, Iowa, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00754598?

The interventions under investigation include: Tomosynthesis digital mammography imaging system (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00754598?

This trial is sponsored by Hologic, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial