Evaluation of C-arm PCD-CBCT for Image-Guided Interventions
ConditionImaging
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Unable to provide informed consent on their own behalf due to cognitive impairment
Pregnant or breastfeeding
Trial population
Patients undergoing a SOC image-guided intervention of the head or body
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
C-arm PCD-CBCT
DeviceA single research PCD-CBCT scan will be performed directly after the participant's SOC scan.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Patients with SOC image-guided intervention1 intervention
Trial outcomes
Primary outcomes
1
Mean Confidence Score for Calcifications
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.
Time frame
after participant data collection is complete (up to 1 year)2
Mean Confidence Score for Metal Artifacts
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.
Time frame
after participant data collection is complete (up to 1 year)3
Area Under the Curve (AUC) for Calcification Detection
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.
Time frame
image analysis will proceed after participant data collection is complete (up to 2 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: