Study of Monochromatic X-ray Mammography System

This research study is looking at a new 2-D Monochromatic X-ray Mammography System. This system uses a special type of X-ray that may create better images with less radiation than regular mammograms. The study wants to see if this new system works as well as or better than traditional mammography. You may be able to join if you are a woman aged 40 or older, have had a mammogram before, and have not had breast cancer surgery or treatment. The study aims to enroll 52 participants, but its current recruitment status is unclear.

Study design
This is a single-arm, non-blinded study that will compare the new system to traditional mammography. It plans to enroll 52 participants.
What's involved
You would have a mammogram with the new system during one visit, and possibly a follow-up visit up to 7 days later.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured from enrollment to the end of your visit, or up to 7 days after if needed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07219797

Study of Monochromatic X-ray Mammography System

Not Yet Recruiting
NAAges 40+InterventionalScreening
Imagine Scientific, Inc.
~52 participants
Updated 2026-03-25 on ClinicalTrials.gov
What's tested:2-D Monochromatic X-ray Mammography System

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammography
Measured over Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)
Breast Imaging
Breast Cancer
1 sites across 1 states
North Carolina1
  • Lars Grimm, MD · PRINCIPAL_INVESTIGATOR · Duke Health

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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
  • Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammographyEnrollment 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. \[Likert scale 1-3. Higher score is a better outcome\]