Clinical trial NCT06691659: Next-Generation Photon-Counting CT Technology: Development and Clinical Evaluation
Official title: Next-Generation Photon-Counting CT Technology: Development and Clinical Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiation Protection
Image Enhancement
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Canon Medical Systems, USA
First posted: 2024-11-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruited patients are scheduled to undergo a routine CT scan (with or without contrast) 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.

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.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 89.
* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
* Not pregnant (based on attestation)

Exclusion Criteria:

* Pregnant women will not be included. All females of childbearing potential must attest that they are not pregnant before CT imaging.
* Participants with a known contrast allergy.
* Any current medical condition, illness, or disorder, as assessed by medical record review and/or self-reported, that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania - Center for Advanced Computed Tomography Imaging Services (CACTIS)
state: Pennsylvania
Study officials:
affiliation: UPENN Radiology
name: Peter B Noel, PhD
role: PRINCIPAL_INVESTIGATOR
References: