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Not yet recruiting NCT07219797

Study of Monochromatic X-ray Mammography System

No phase Interventional Breast Imaging Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 2-D Monochromatic X-ray Mammography System.
Who it may be relevant to
Registry conditions: Breast Imaging, Breast Cancer. Basic parameters: from 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

A research study to find out if an investigational mammography machine is effective in producing high-quality images using a lower radiation dose than traditional mammography.

Detailed description

Prospective, single-arm, non-blinded, comparative/observational study.

Phase 1: Verify operation of monochromatic system and optimize the monochromatic energies and exposure times for a range of breast thicknesses.

Phase 2: Test the performance of the monochromatic system in comparison to traditional 2-D mammography for a range of clinical/imaging scenarios.

Phase 3: Test the performance of the monochromatic system using reduced breast compression.

Interventions

  • Device 2-D Monochromatic X-ray Mammography System
    Monochromatic x-ray mammography system produces superior images as compared to conventional 2-D and 3-D mammography while using a lower radiation dose.

Primary outcome measures

  • Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammography [Time frame: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)]
Secondary outcome measures (4)
  • Relevant pathologies identified by monochromatic-based x-ray as compared to conventional mammography [Time frame: End of visit 1 (or up to 7 days following visit 1, if needed)]
  • Lower breast compression with monochromatic-based x-ray mammography [Time frame: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)]
  • Quality of images produced by monochromatic-based x-ray mammography at lower radiation dose. [Time frame: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)]
  • Patient satisfaction with monochromatic x-ray mammography system [Time frame: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)]

Eligibility criteria

Inclusion criteria

  • Female
  • 40 yrs of age or older
  • Capable of giving informed consent
  • Prior history of mammography

Exclusion criteria

  • Pregnancy
  • History of breast cancer surgery, including lumpectomy or mastectomy
  • Currently undergoing treatment for breast cancer
  • Previous breast augmentations

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Duke Cancer Center — Durham

Identifiers

NCT: NCT07219797 · Pro00115443

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗