New Mammography Technology for Breast Cancer Screening
Trial Summary
What is the purpose of this trial?
This trial is testing a new device designed to help screen for and diagnose breast cancer. It targets individuals who are undergoing breast cancer screening and diagnosis. The device works by scanning breast tissue to identify any unusual changes or lumps that could indicate cancer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the IzoView Breast CT Imaging System treatment for breast cancer screening?
Research on breast CT systems shows promising results, with excellent anatomical detail and good visualization of tumors, similar to the IzoView system. Initial studies indicate that breast CT can effectively enhance tumor visualization, especially with iodine contrast, suggesting it may play a role in breast cancer imaging.12345
Is the IzoView Breast CT Imaging System safe for humans?
The breast CT system, including the IzoView, has been tested on 55 women, including healthy volunteers and those with a high likelihood of breast cancer, using radiation doses similar to standard mammography. Initial results show promising imaging quality, and the system is undergoing further safety and performance evaluations.13567
How is the IzoView Breast CT Imaging System different from other breast cancer screening treatments?
The IzoView Breast CT Imaging System is unique because it uses a dedicated computed tomography (CT) system to scan the breast in a pendant position, providing detailed 3D images without compressing the breast, unlike traditional mammography. This method offers excellent anatomical detail and visualization of soft tissue and microcalcifications, potentially improving the detection of breast cancer, especially in dense breast tissue.13689
Eligibility Criteria
This trial is for women at least 35 years old who need a mammogram or breast biopsy, regardless of race and ethnicity. It's not for those who may be pregnant, cannot stand independently due to being wheelchair-bound, have breast implants, pacemakers, or IV ports in the area where the mammogram takes pictures, or have been in this study before.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo investigational mammogram exams to evaluate the safety and efficacy of the device
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Investigational Device (Mammography Technology)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hologic, Inc.
Lead Sponsor