Imaging
Conditions
Keywords
image-guided intervention
Brief summary
The overarching objective of the project is to develop a new C-arm interventional x-ray imaging platform that integrates both a photon counting detector and a flat panel detector to provide high image quality and quantitative spectral computed tomography (CT) image guidance will be developed to enable more accurate and safe interventional procedures for patients.
Detailed description
The objective of this pilot study is to assess the feasibility of acquiring high-quality images using new imaging concepts and methods. All imaging will be performed in addition to standard-of-care procedures and will not influence clinical decisions or patient management. The endpoint of this project includes: 1) PCD-CBCT data will be processed to generate virtual non-iodine images for evaluating contrast extravasation, as well as virtual monoenergetic (VME) images. 2) Images will be analyzed retrospectively to evaluate image quality and explore potential clinical benefits of PCD-CBCT compared to flat panel detector cone beam CT (FPD-CBCT) and multidetector computed tomography (MDCT).
Interventions
DEVICEC-arm PCD-CBCT
A single research PCD-CBCT scan will be performed directly after the participant's SOC scan.
Sponsors
University of Wisconsin, Madison
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Not pregnant or breastfeeding * Scheduled to receive image-guided intervention (IGI) of the head or the body * Pre-treatment multidetector computed tomography (MDCT) images available
Exclusion criteria
* Unable to provide informed consent on their own behalf due to cognitive impairment * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Confidence Score for Calcifications | after participant data collection is complete (up to 1 year) | MDCT, PCD-CBCT, and FPD-CBCT images will be co-registered and displayed on a clinical monitor using a customized software that allows the users to toggle between energy bin images. At least 4 readers with a broad spectrum of clinical experiences (radiology residents, interventional radiology and neurosurgery fellows, and experienced physician co-investigators) will independently identify calcifications and extravasated iodine contrast (if available) and provide a 1 (low) to 5 (high) confidence score on each image. |
| Mean Confidence Score for Metal Artifacts | after participant data collection is complete (up to 1 year) | MDCT, PCD-CBCT, and FPD-CBCT images will be co-registered and displayed on a clinical monitor using a customized software that allows the users to toggle between energy bin images. At least 4 readers with a broad spectrum of clinical experiences (radiology residents, interventional radiology and neurosurgery fellows, and experienced physician co-investigators) will independently identify metal artifacts (if any) and provide a 1 (low) to 5 (high) confidence score on each image. |
| Area Under the Curve (AUC) for Calcification Detection | image analysis will proceed after participant data collection is complete (up to 2 years) | For all reading studies, the order of subjects and imaging modality (MDCT, FPD-CBCT, and PCD-CBCT) will be randomized; three separate reading sessions will be implemented with a washout period of at least 3 months between sessions. For calcification and iodine staining detection in the human subjects, the receiver operating characteristic (ROC) curves will be calculated using the maximum-likelihood method with the binormal model. The 95% confidence interval (CI) of each ROC curve will be estimated and the area under the curve (AUC) and its 95% CI will be calculated. |
Countries
United States
Contacts
CONTACTRadiology Studies
PRINCIPAL_INVESTIGATORGuang-Hong Chen, PhD
UW School of Medicine and Public Health
Outcome results
None listed