Common use of CE-CBBCT PROCEDURE Clause in Contracts

CE-CBBCT PROCEDURE. The subjects will first have a pre-contrast CBBCT scan. Iodinated contrast will be injected intravenously, and then another CBBCT scans will be performed to capture the tumor vasculature enhancement. Features to look for are degree of enhancement pattern of the lesion as compared to surrounding pattern. Delay times and contrast volume/rate will be determined initially through previous CT studies then optimized through this CBBCT study. Each CBBCT scan takes 10 seconds and delivers a glandular dose similar to a diagnostic mammography exam. State board-certified and Mammography Quality Standards Act (MQSA) qualified mammographers will evaluate the CBBCT high resolution 3D images and compare them to the subjects’ mammograms. If the subject had an MRI or ultrasound, then these would be compared as well. If the patient’s diagnostic outcome is BIRADS 4 and above and has biopsy or surgery, pathology will provide final confirmation. If the patient’s diagnostic outcome is BIRADS 1, 2, 3, follow up results will provide final confirmation. Physicians familiar with contrast-enhanced multislice CT procedures will be available during the CE- CBBCT procedures and will advise on modifications. Once all the projections are acquired, projections will then be used for volume reconstruction. Since a malignant tumor has many blood vessels, it will be enhanced in the post-contrast reconstructed image. The contrast enhancement of the malignant tumor will be quantified by CT number measurements. To explore dynamic contrast-enhanced vasculature patterns (wash-in, wash-out), we propose to select the scan at various delay times on different subjects with similar lesions to see if we can get preliminary data on this functional effect while keeping the dose to individual subjects low. The radiographic technique will be 49 kVp, 8 ms/projection image, and 300 images per scan. The mA will be automatically selected by the CBBCT system from 50 to 200 mA, depending on size and density of the breast. This translates to a range of average glandular dose to the breast from ~4 mGy to ~16 mGy per scan, depending on breast size and density, or similar to the subject’s diagnostic mammogram. In this study, the dose for a full two-scan contrast imaging will be ~ 8 to 32 mGy, or similar to two diagnostic mammography exams.

CE-CBBCT PROCEDURE. The subjects will first have a pre-contrast CBBCT scan. Iodinated contrast will be injected intravenously, and then another CBBCT scans will be performed to capture the tumor vasculature enhancement. Features to look for are degree of enhancement pattern of the lesion as compared to surrounding pattern. Delay times and contrast volume/rate will be determined initially through previous CT studies then optimized through this CBBCT study. Each CBBCT scan takes 10 seconds and delivers a glandular dose similar to a diagnostic mammography exam. State board-certified and Mammography Quality Standards Act (MQSA) qualified mammographers will evaluate the CBBCT high resolution 3D images and compare them to the subjects’ mammograms. If the subject had an MRI or ultrasound, then these would be compared as well. If the patient’s diagnostic outcome is BIRADS 4 and above and has biopsy or surgery, pathology will provide final confirmation. If the patient’s diagnostic outcome is BIRADS 1, 2, 3, follow up results will provide final confirmation. Physicians familiar with contrast-enhanced multislice CT procedures will be available during the CE- CE-CBBCT procedures and will advise on modifications. Once all the projections are acquired, projections will then be used for volume reconstruction. Since a malignant tumor has many blood vessels, it will be enhanced in the post-contrast reconstructed image. The contrast enhancement of the malignant tumor will be quantified by CT number measurements. To explore dynamic contrast-enhanced vasculature patterns (wash-in, wash-out), we propose to select the scan at various delay times on different subjects with similar lesions to see if we can get preliminary data on this functional effect while keeping the dose to individual subjects low. The radiographic technique will be 49 kVp, 8 ms/projection image, and 300 images per scan. The mA will be automatically selected by the CBBCT system from 50 to 200 160 mA, depending on size and density of the breast. This translates to a range of average glandular dose to the breast from ~4 mGy to ~16 ~13 mGy per scan, depending on breast size and density, or similar to the subject’s diagnostic mammogram. In this study, the dose for a full two-scan contrast imaging will be ~ 8 to 32 mGy, or similar to two diagnostic mammography exams.