Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-14 @ 6:37 PM
Study NCT ID:
NCT06691659
Status:
RECRUITING
Last Update Posted:
2025-10-14
First Post:
2024-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Next-Generation Photon-Counting CT Technology: Development and Clinical Evaluation
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Next-Generation Photon-Counting CT Technology: Development and Clinical Evaluation
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CT-DACE
Brief Summary:
This project aims to develop and evaluate a next-generation photon-counting CT prototype, and assess whether next-generation photon-counting CT--which enables reduced radiation dose, high spatial resolution, and spectral imaging--would facilitate improved diagnostic performance for abdominal, cardiothoracic, musculoskeletal, and neuroimaging.
Detailed Description:
This protocol aims to assess the diagnostic benefits of a next-generation Photon-Counting Computed Tomography (PCCT) system in patients undergoing routine CT imaging.
Recruitment will be conducted among patients scheduled for CT scans (with or without contrast agent) at the Perelman Center for Advanced Medicine. Patients in the study will undergo abdominal, cardiovascular, chest, musculoskeletal, and neuroimaging scans.
The design involves 50 participants per body region to gather preliminary data and assess diagnostic benefits for future research and clinical translation.
This a total of 250 patients for the initial study.
Analyses will be conducted as needed, based on the specific validation or quantitative measures required for each clinical CT scan. This study will involve three radiologists for each cohort, selected based on their training in the specific anatomical region of interest, analyzing images from PCCT scanning. They will interpret both conventional CT slices and the additional spectral and high-resolution data provided by the PCCT. The images will be reviewed on a state-of-the-art workstation with a high-resolution monitor. Performance metrics will be set individually for each anatomical region.
Recruitment will be conducted among patients scheduled for CT scans (with or without contrast agent) at the Perelman Center for Advanced Medicine. Patients in the study will undergo abdominal, cardiovascular, chest, musculoskeletal, and neuroimaging scans.
The design involves 50 participants per body region to gather preliminary data and assess diagnostic benefits for future research and clinical translation.
This a total of 250 patients for the initial study.
Analyses will be conducted as needed, based on the specific validation or quantitative measures required for each clinical CT scan. This study will involve three radiologists for each cohort, selected based on their training in the specific anatomical region of interest, analyzing images from PCCT scanning. They will interpret both conventional CT slices and the additional spectral and high-resolution data provided by the PCCT. The images will be reviewed on a state-of-the-art workstation with a high-resolution monitor. Performance metrics will be set individually for each anatomical region.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: