A clinical trial investigating the innovative 2-D Monochromatic X-ray Mammography System has been listed on ClinicalTrials.gov, marking an important step forward in breast cancer imaging technology. Sponsored by Imagine Scientific, Inc., in partnership with Duke Health, this study aims to assess the potential benefits of the system for enhancing breast cancer diagnosis accuracy and safety. It has not yet started recruiting participants.
What changed?
On October 22, 2025, a new mammography clinical trial was recorded on ClinicalTrials.gov under the identifier NCT07219797. This trial focuses on evaluating the efficacy and safety of a 2-D Monochromatic X-ray Mammography System developed by Imagine Scientific, Inc. and supported by Duke Health.
The system represents a promising advancement in breast imaging, aiming to improve tumor detection while reducing radiation exposure commonly associated with conventional mammography methods.
What are the clinical trial objectives?
The primary goal of this study is to validate whether the monochromatic X-ray technology provides superior imaging results compared to standard mammography systems. This includes assessing the system’s impact on image clarity, diagnostic accuracy, and potential reductions in unnecessary biopsies.
Additionally, the trial will evaluate the device’s overall safety profile, focusing on minimizing radiation exposure during imaging procedures.
What is the device design?
The system is designed to use monochromatic X-ray technology for high-precision imaging. Unlike conventional systems that utilize broad-spectrum X-rays, this device filters X-rays to a single wavelength, enhancing tissue visualization and differentiation for improved cancer detection.
The manufacturers assert that this technology could reduce the risk of image artifacts, leading to a clear view of abnormalities and potentially lowering false-positive rates.
Frequently Asked Questions
- What conditions does the trial address?
The trial addresses breast imaging and breast cancer detection. - Who is sponsoring the study?
Imagine Scientific, Inc. and Duke Health are listed as the sponsors. - When will recruitment start?
As of October 2025, the trial has not yet begun recruiting participants.
Conclusion
This clinical trial underscores ongoing innovation in imaging technology designed to enhance breast cancer diagnosis. For professionals in clinical and regulatory fields, monitoring the progress of this study may provide insights into the future of medical imaging devices and the role of monochromatic X-rays in public health.
Disclaimer
This content is intended for informational purposes and should not be considered legal advice. For specific guidance, consult a regulatory expert.
Full announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07219797?term=medical+device