Translational Development of Photon-counting CT Imaging

NCT03878134 | Completed Results

• 2 other identifiers: 19007019-CC-0070
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Using an investigational CT scanner which uses a new type of detector to capture X-rays, (a photon counting CT detector), the goal of this experimental study is to compare conventional CT images to CT images using the photon counting detector in patients undergoing CT scans for clinically indicated reasons. The main question it aims to answer is whether the images produced using the new detectors are superior in quality. Participants will undergo the clinically indicated CT images and the photon counting detector CT images of a limited area during the same examination time.

Conditions

Cancer; Inflammatory Disease; Vascular Diseases; Metabolic Bone Disease

Keywords

Photon Counting CT; Computed Tomography; Photon Counting Detectors

Outcome Measures

Primary Outcomes (1)

• Mean Difference in Diagnostic Image Quality Grading of Photon Counting CT vs Conventional CT Images.

  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.

  2 years and 3 months, 27 months

Study Arms (1)

Patients undergoing conventional and Photon Counting CT scan on the investigational scanner

EXPERIMENTAL

18 and older patients who undergo the conventional CT scan and the photon counting CT (PCCT) scan. Patient's images on the conventional scanner provide internal control to compare to the PCCT images.

Device: PHOTON COUNTING CT Scanner

Interventions

PHOTON COUNTING CT Scanner DEVICE

Enrolled patients will undergo the requested clinical diagnostic CT study on the investigational system using the standard detector, with or without IV and/or oral contrast as indicated and an limited scan of one body region using the PCCT detector. Both scans are able to be performed on the same scanner during the same examination.

Patients undergoing conventional and Photon Counting CT scan on the investigational scanner

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NIH patients currently on an NIH research protocol who are referred to RAD\&IS for CT examination as part of that research protocol
• years old or greater
• Able to understand and sign informed consent

You may not qualify if:

• Studies that specifically require simultaneous dual source CT scan capability or where dual source CT scan is requested
• Studies ordered for an emergency indication
• Pregnant women. Subjects of child-bearing potential will undergo serum or urine pregnancy testing within 72 hours before examination. Post-menopausal and surgically sterilized subjects are automatically exempt from this testing
• Lactating women who are unable to stop breast feeding for 24 hours following the administration of contrast
• Body weight \>500 lbs (227 kg) or a body circumference that prevents the study subject from lying flat in the scanner
• Patients who have undergone PCCT examination within the past year.
• Any contraindications that the research team identifies from the subject, RAD\&IS CT questionnaires, and/or History and Assessment
• Employees or staff supervised by the Principal Investigator or an Associate will not be recruited to participate

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Symons R, Pourmorteza A, Sandfort V, Ahlman MA, Cropper T, Mallek M, Kappler S, Ulzheimer S, Mahesh M, Jones EC, Malayeri AA, Folio LR, Bluemke DA. Feasibility of Dose-reduced Chest CT with Photon-counting Detectors: Initial Results in Humans. Radiology. 2017 Dec;285(3):980-989. doi: 10.1148/radiol.2017162587. Epub 2017 Jul 28.

  PMID: 28753389 BACKGROUND

• Pourmorteza A, Symons R, Henning A, Ulzheimer S, Bluemke DA. Dose Efficiency of Quarter-Millimeter Photon-Counting Computed Tomography: First-in-Human Results. Invest Radiol. 2018 Jun;53(6):365-372. doi: 10.1097/RLI.0000000000000463.

  PMID: 29595753 BACKGROUND

• Pourmorteza A, Symons R, Reich DS, Bagheri M, Cork TE, Kappler S, Ulzheimer S, Bluemke DA. Photon-Counting CT of the Brain: In Vivo Human Results and Image-Quality Assessment. AJNR Am J Neuroradiol. 2017 Dec;38(12):2257-2263. doi: 10.3174/ajnr.A5402. Epub 2017 Oct 5.

  PMID: 28982793 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasms; Vascular Diseases; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

The PCCT detector and investigational CT scanner itself were in development at the time of the trial. The detector and scanner platform has been developed by industry since this time. These results are not predictive of the performance of the FDA approved PCCT scanner which was approved in October 2021.

Results Point of Contact

• Title: Dr. Elizabeth Jones Chief, Radiology and Imaging Sciences
• Organization: NIH Clinical Center

ejones@cc.nih.gov

3012634853

Study Officials

• Elizabeth C Jones, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Model Details: Enrolled patients may be scanned on the investigational Photon Counting CT scanner. Conventional images also obtained for comparison using the same scanner at the same time.

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 18, 2019
• Study Start: October 1, 2019
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: November 1, 2023
• Results First Posted: September 21, 2023

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)