Monochromatic X-ray Mammography for Breast Imaging

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Imagine Scientific, Inc.

Disqualifiers: Pregnancy, Breast cancer surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of mammography machine, the 2-D Monochromatic X-ray Mammography System, to determine if it can produce high-quality breast images with less radiation than standard machines. The study compares this new technology to the standard mammogram to ensure its effectiveness. It seeks women aged 40 or older who have previously had a mammogram. Those who have undergone breast cancer surgery or are currently receiving treatment for breast cancer are not eligible.

As an unphased trial, this study allows participants to contribute to advancements in breast imaging technology.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on imaging, so it's unlikely that your medications will be affected, but you should confirm with the trial organizers.

What prior data suggests that this mammography machine is safe for breast imaging?

Previous research has shown that monochromatic X-rays hold promise for breast imaging. They reduce the radiation dose by 5 to 10 times compared to traditional mammograms, resulting in less radiation exposure while still providing clear images. Studies have reported no negative effects, suggesting that this method is well-tolerated. This indicates that the 2-D Monochromatic X-ray Mammography System offers a safer option for breast imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about monochromatic X-ray mammography because it has the potential to offer clearer breast imaging with a lower dose of radiation compared to standard mammography. Unlike conventional systems that use a broad spectrum of X-ray energies, this technique uses a single wavelength of X-rays, which can enhance image contrast and reduce radiation exposure. This innovation could lead to safer, more effective breast cancer screenings, making it a promising advancement in mammography technology.

What evidence suggests that this mammography system is effective for breast imaging?

This trial will compare the 2-D Monochromatic X-ray Mammography System, a new type of X-ray system for mammograms, with standard mammography. Research has shown that this new system can produce images as good as those from traditional methods but with less radiation. Studies have found that it performs as well as older systems, using special X-rays to create clearer images, which might aid in more effective breast cancer detection. This technology simplifies the imaging process and potentially increases safety due to the lower radiation dose. These findings suggest that this new system could be a promising option for breast imaging. ^{1 2 3 6 7}

Who Is on the Research Team?

Lars Grimm, MD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for women aged 40 or older who can give informed consent and have had a mammogram before. It's not for those who are pregnant, have had breast cancer surgery like lumpectomy or mastectomy, are currently being treated for breast cancer, or have had breast augmentations.

Inclusion Criteria

Prior history of mammography

I am 40 years old or older.

I am female.

Exclusion Criteria

Pregnancy

I have had surgery for breast cancer.

I am currently receiving treatment for breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phase 1: System Verification and Optimization

Verify operation of monochromatic system and optimize the monochromatic energies and exposure times for a range of breast thicknesses.

2 weeks

1 visit (in-person)

Phase 2: Comparative Performance Testing

Test the performance of the monochromatic system in comparison to traditional 2-D mammography for a range of clinical/imaging scenarios.

2 weeks

1 visit (in-person)

Phase 3: Reduced Compression Testing

Test the performance of the monochromatic system using reduced breast compression.

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 2-D Monochromatic X-ray Mammography System

Trial Overview The study is testing a new type of mammography machine that uses monochromatic X-rays to see if it can produce high-quality images with less radiation than the usual mammograms.

How Is the Trial Designed?

Group I: Test device vs standard of care Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Imagine Scientific, Inc.

Lead Sponsor

Duke Health

Collaborator

Trials

6

Recruited

3,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07219797

Study of Monochromatic X-ray Mammography System Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammography ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0720048X21004423

Monochromatic X-rays: The future of breast imaging This article summarizes the technology of monochromatic X-rays, results obtained so far and the potential for improving currently used mammographic techniques.

3. ejradiology.com ejradiology.com/article/S0720-048X(21)00442-3/fulltext

Monochromatic X-rays: The future of breast imaging Contrast-enhanced digital mammography with monochromatic X-rays is shown to provide a simpler and more effective technique at substantially lower radiation ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8757313/

Comparative Effectiveness of Digital Breast Tomosynthesis ... This observational study evaluated breast cancer screening outcomes among women screened with 2 D mammography vs DBT. We used deidentified administrative data ...

5. withpower.com withpower.com/trial/phase-breast-imaging-9-2025-92ba7

Monochromatic X-ray Mammography for Breast Imaging A research study to find out if an investigational mammography machine is effective in producing high-quality images using a lower radiation dose than ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34562745/

Monochromatic X-rays: The future of breast imaging Results: Monochromatic X-rays reduce the radiation dose per mammogram by a factor of 5 to 10 times. For phantom simulating thick breast (9 cm), ...

7. densebreast-info.org densebreast-info.org/screening-technologies/2d-3d-mammography-density-assessment/

2D/3D Mammography, Density Assessment Software Adding 3D/tomosynthesis to 2D digital mammography increases cancer detection by 1 to 2 cancers per thousand individuals screened. In individuals ...