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NCT Number: NCT07219797

Study of Monochromatic X-ray Mammography System

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.

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Key information

Conditions

Breast Imaging Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location contact

Amy Cuddington

CONTACT

[email protected]

919-684-3296

Lars Grimm, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2-D Monochromatic X-ray Mammography System

Device

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 outcomes

  1. 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)

    Demonstrate that a 2-D monochromatic X-ray mammography system can produce mammographic images using lower radiation dose (at least 20% less than conventional mammography), yet, not inferior to conventional mammography. [Likert scale 1-3. Higher score is a better outcome]

Secondary outcomes

  1. 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)

    Assess ability of monochromatic-based X-ray mammography to identify relevant pathologies in subjects with dense breast issue (BI-RADS density categories C and D) otherwise not detected in scans produced with conventional mammography. [Likert scale 1-3. Higher score is a better outcome]

  2. 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)

    Assess ability of monochromatic-based x-ray mammography to produce quality images with lower breast compression. [Likert scale 1-3. Higher score is a better outcome]

  3. 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)

    Demonstrate ability of monochromatic-based mammography to produce quality images at radiation doses below maximum FDA-approved radiation dose. [Likert scale 1-3. Higher score is a better outcome]

  4. 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)

    Assess patient satisfaction with monochromatic x-ray mammography system. [Likert scale 1-5. Higher score is a better outcome.]

Sponsors and collaborators

Lead sponsor

Imagine Scientific, Inc.

Industry

Collaborators

  • Duke Health

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 22, 2025
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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