Status:

NOT_YET_RECRUITING

Study of Monochromatic X-ray Mammography System

Lead Sponsor:

Imagine Scientific, Inc.

Collaborating Sponsors:

Duke Health

Conditions:

Breast Imaging

Breast Cancer

Eligibility:

FEMALE

40+ years

Phase:

NA

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.

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 brea...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

October 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2026

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT07219797

Start Date

October 1 2025

End Date

July 1 2026

Last Update

October 22 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Duke Cancer Center

Durham, North Carolina, United States, 27710