Study of Monochromatic X-ray Mammography System

NCT07219797 | Not Yet Recruiting FDA Device

• 1 other identifier: Pro00115443
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Imaging; Breast Cancer

Keywords

Mammography

Outcome Measures

Primary Outcomes (1)

• Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammography

  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. \[Likert scale 1-3. Higher score is a better outcome\]

  Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)

Secondary Outcomes (4)

• Relevant pathologies identified by monochromatic-based x-ray as compared to conventional mammography

  End of visit 1 (or up to 7 days following visit 1, if needed)

• Lower breast compression with monochromatic-based x-ray mammography

  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.

  Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)

• Patient satisfaction with monochromatic x-ray mammography system

  Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)

Study Arms (1)

Test device vs standard of care

EXPERIMENTAL

Demonstrate that a 2-D monochromatic x-ray mammography system can produce mammographic images using lower radiation dose, yet not inferior to conventional mammography.

Device: 2-D Monochromatic X-ray Mammography System

Interventions

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.

Test device vs standard of care

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Imagine Scientific, Inc.: lead
• Duke Health: collaborator

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lars Grimm, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 22, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)