None listed
Conditions
Brief summary
This study aims to evaluate the diagnostic performance of PB-CT in a real-world clinical setting and compare the scans to the standard of care (mammography). Who is it for? You may be eligible to join this study if you are a woman aged 50 - 70 years old, have had a mammogram in the past 6 months with no detected breast cancer and have no metal clips in your breasts. You will need to be able to go to the ANSTO facility in Clayton Victoria and able to lie face-down for a couple of minutes. Study details All participants who meet the eligibility criteria in this study will undergo Propagation-Based Phase-Contrast CT (PB-CT) (intervention) for breast imaging. After the intervention, image quality metrics of the scan will be assessed and participants will be surveyed regarding the comfort of the scan. It is hoped that this research project will help us understand how acceptable this new test is for patients, provide imaging data sets to teach radiologists how to read PB-CT scans, and allow diagnostic quality assessments to be made. Together, this research will help guide future improvements in breast screening and diagnostic imaging for cancer detection and treatment planning.
Interventions
The study will be a pilot study using Propagation-Based Phase-Contrast CT (PB-CT) (intervention) for breast imaging for the first time. This will be compared to the current standard of care which is mammography. This is because the current stage of the project is serving as a proof of concept and not as a diagnostic tool but the study will be eventually expanded once the initial results of the pilot study are analysed, and subsequently help inform how PB-CT contributes towards breast cancer screening, diagnosis, and treatment planning. Propagation-based CT (PB-CT) is an advanced type of imaging that creates incredibly detailed 3D pictures of the body. It uses X-rays, just like regular mammograms or CT scans, but it also captures the visibility of fine details, especially soft tissues or subtle changes that might not be seen on a standard CT scan. Standard imaging, such as mammograms and CT, relies on the absorption of x-rays through the body. However, PB-CT uses refraction as well as absorption of x-rays in tissue, and shows particular promise in breast imaging due to its superior sensitivity to soft-tissue tumours. This enables better-quality images to be obtained at lower radiation doses compared to conventional absorption-based CT imaging. The PB-CT scan takes 12-15 seconds for each breast, and the total set-up is expected to take less than 5 minutes. Participants will be asked to complete some surveys before and after the PB-CT scan, have the procedure explained to them before starting, and ask any questions so the total time spent at ANSTO may be 30 minutes. A research nurse and radiographer will go over consent with the participant. A radiographer will position and scan the participant with scientists and physicists in the console room. Radiologists will review the images after the scans are complete and processed. Prior to attending, participants will be screened by the research nurse to ensure they meet the inclusion criteria, including are they able to lie prone for a couple of minutes (to fulfil the scan), and if they have had a mammogram in the past 6 months. Access to their mammogram will be needed prior to attending for the PB-CT scan, and it will be used to compare to the PB-CT scan.
Sponsors
Study design
Eligibility
Inclusion criteria
o Women aged between 50-70 years old o Have had a mammogram in the past 6 months with no detected breast cancer o Able to go to the ANSTO facility in Clayton, Victoria o Able to lie prone (face-down)
Exclusion criteria
o Has implants or metal clips in their breast (for example, a previous breast biopsy)