Trial Outcomes & Findings for Translational Development of Photon-counting CT Imaging (NCT NCT03878134)
NCT ID: NCT03878134
Last Updated: 2023-11-01
Results Overview
Mean difference in relative image quality grading of CT images using Photon counting detectors vs. conventional detectors in group of patients with various clinical conditions. Scale name "Visual grading analysis (VGA)" . Expert radiologist observers compare the relative grades of the images from the PCCT to the grades of the same patient's reference images from conventional CT acquired at the same time. The visual grading scale incorporates technical factors in the acquisition and image display (such as contrast, noise and presence of artifacts and post processing). Grading is based on 5 point scale. 1- lowest image quality, 5- highest image quality. 5 is a better result. Scale as follows: 1 Images not usable- severe limitations for diagnostic use, 2 Limited -some loss of information, significant limitations for clinical use, 3 Adequate -moderate limitations for diagnostic use, 4 Good-minimal limitations for clinical use, 5 Excellent- no limitations for clinical diagnosis.
COMPLETED
NA
67 participants
2 years and 3 months, 27 months
2023-11-01
Participant Flow
Patients referred for diagnostic CT scan with clinical history or at risk status for conditions such as urologic cancers, lung cancers, as well as patients with conditions such as inflammatory lung or soft tissue diseases, arterial disorders of small vessels, or metabolic bone disease.
Participant milestones
| Measure |
Patients Enrolled to Receive the Intervention PCCT CT Scan
67 enrolled participants
PHOTON COUNTING CT: Enrolled patients that could not undergo the requested clinical diagnostic CT study on the PCCT system using the standard detector, and the abbreviated PCCT scan as part of the examination. This occurred due to scheduling conflicts, and scanner down time failure to calibrate or other software Quality control failures. Patients received their CT exams on other conventional scanners and were removed from the protocol without the PCCT intervention.
For patients who underwent the investigational scan, they completed the protocol immediately following the scan.
|
|---|---|
|
Overall Study
STARTED
|
67
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Patients Enrolled to Receive the Intervention PCCT CT Scan
67 enrolled participants
PHOTON COUNTING CT: Enrolled patients that could not undergo the requested clinical diagnostic CT study on the PCCT system using the standard detector, and the abbreviated PCCT scan as part of the examination. This occurred due to scheduling conflicts, and scanner down time failure to calibrate or other software Quality control failures. Patients received their CT exams on other conventional scanners and were removed from the protocol without the PCCT intervention.
For patients who underwent the investigational scan, they completed the protocol immediately following the scan.
|
|---|---|
|
Overall Study
Scanner downtime or scheduling conflict
|
11
|
Baseline Characteristics
Some patients were enrolled however were unable to receive the intervention of PCCT on the investigational CT scanner due to scanner downtime.
Baseline characteristics by cohort
| Measure |
Patients Referred for Diagnostic CT Scans
n=67 Participants
up to 750 male or female, 18 and older patients
PHOTON COUNTING CT: Enrolled patients will undergo the requested clinical diagnostic CT study on the PCCT system using the standard detector, with or without IV and/or oral contrast as indicated. They will also undergo a brief PCCT scan as part of the examination. The scan will thus include both clinically indicated radiation exposure with the standard detector and research radiation with the PCCT detector.
|
|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 14.5 • n=99 Participants • Some patients were enrolled however were unable to receive the intervention of PCCT on the investigational CT scanner due to scanner downtime.
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants • There were patients who were enrolled but were unable to undergo the intervention , PCCT CT scan due to scanner downtime.
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants • There were patients who were enrolled but were unable to undergo the intervention , PCCT CT scan due to scanner downtime.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Adults referred for diagnostic CT scan
|
67 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 years and 3 months, 27 monthsPopulation: Patients with various conditions including cancer who underwent their routine conventional CT scan with additional PCCT images obtained for comparison.
Mean difference in relative image quality grading of CT images using Photon counting detectors vs. conventional detectors in group of patients with various clinical conditions. Scale name "Visual grading analysis (VGA)" . Expert radiologist observers compare the relative grades of the images from the PCCT to the grades of the same patient's reference images from conventional CT acquired at the same time. The visual grading scale incorporates technical factors in the acquisition and image display (such as contrast, noise and presence of artifacts and post processing). Grading is based on 5 point scale. 1- lowest image quality, 5- highest image quality. 5 is a better result. Scale as follows: 1 Images not usable- severe limitations for diagnostic use, 2 Limited -some loss of information, significant limitations for clinical use, 3 Adequate -moderate limitations for diagnostic use, 4 Good-minimal limitations for clinical use, 5 Excellent- no limitations for clinical diagnosis.
Outcome measures
| Measure |
Patients Enrolled in Protocol
n=56 Participants
Enrolled patients referred or invited who will undergo their clinically indicated diagnostic CT study on the PCCT system using the standard detector. They will also undergo a PCCT scan on the system restricted in extent to an organ or body part as part of the examination.
|
|---|---|
|
Mean Difference in Diagnostic Image Quality Grading of Photon Counting CT vs Conventional CT Images.
|
0.947368421 score on a scale
Standard Deviation 0.478877133
|
Adverse Events
Patients Receiving the Intervention PCCT CT Scan
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Elizabeth Jones Chief, Radiology and Imaging Sciences
NIH Clinical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place