Study of Monochromatic X-ray Mammography System

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Imagine Scientific, Inc.
Study ID
NCT07219797
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Oct 2025
Primary completion
Mar 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Test device vs standard of care
    Demonstrate that a 2-D monochromatic x-ray mammography system can produce mammographic images using lower radiation dose, yet not inferior to conventional mammography.

Primary Outcome Measure

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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Cancer CenterDurhamNorth Carolina27710
Amy Cuddington
[email protected]
919-684-3296
Lars Grimm, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Duke Cancer Center· Durham, NC

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