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CancerNCT03878134

Translational Development of Photon-counting CT Imaging

A study testing PHOTON COUNTING CT Scanner in people with Cancer and Inflammatory Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Inflammatory Disease, Vascular Diseases
What is being tested?
PHOTON COUNTING CT Scanner
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteUnited States
Study dates
1 Oct 2019to 18 Jan 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Translational Development of Photon-Counting CT Imaging

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.

Read the detailed description

NIH develops new imaging techniques as one of its priorities for accelerating science, including methods for non-invasive patient assessments. Computed tomographic (CT) imaging is a mainstay of diagnostic imaging. The latest major technological advance is photon counting CT (PCCT) which uses a new x-ray detector that measures x-ray penetration of the body and the energy of each x-ray photon. NIH Clinical Center will use a prototype Siemens PCCT CounT systems built for clinical investigational use. The scanner can perform standard CT and PCCT imaging. In this protocol, NIH patients already enrolled in a clinical research protocol and who are referred to Radiology for diagnostic CT as part of that research may be enrolled in this study of PCCT. The diagnostic CT scan requested by their medical care team will be performed on the CounT scanner, providing the clinically indicated imaging, along with a single abbreviated PCCT exam of an organ or body part to support PCCT feasibility of the PCCT to provide better images in several small groups of patients with selected medical conditions. The data will be used to characterize quality of the PCCT images and to develop testable hypotheses and new diagnostic applications using PCCT capabilities.

Current CT systems, such as the Siemens SOMATOM Flash, have two x-ray tubes, each paired with an x-ray detector that measures total x-ray penetration of the patient and uses that information to create the images. The CounT scanner is a modified version of the Flash in which one of the two standard detectors has been replaced with a PCCT detector. The two imaging modes for the CounT scanner are (i) standard detector study as in a Flash scanner and (ii) PCCT scan. The patient scan will thus include clinically indicated radiation exposure with the standard detector and research radiation over a limited field with the PCCT detector. The CounT system is sited at the Clinical Center under a CRADA (Cooperative research and development agreement) with Siemens Medical Solutions.

Compared to current scanners, PCCT is expected to offer four major advantages:

  • lower radiation dose
  • greater spatial resolution
  • reduced imaging noise
  • x-ray energy discrimination

As a translational development protocol, all imaging studies are open-label and data may be analyzed as they are collected.

Being tested
PHOTON COUNTING CT Scanner
Keywords
Photon Counting CT, Computed Tomography, Photon Counting Detectors
Medical subject headings
Neoplasms, Vascular Diseases, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PHOTON COUNTING CT ScannerDevice

    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.

Study groups in NCT03878134
Study groupRoleWhat they receive
Patients undergoing conventional and Photon Counting CT scan on the investigational scannerExperimental18 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.
Receives: Device: PHOTON COUNTING CT Scanner

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years and 3 months, 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2019
  2. Study start1 Oct 2019
  3. Primary completion18 Jan 2022
  4. Study completion18 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03878134
Sponsor's protocol ID
190070
Other IDs
19-CC-0070
Status last verified
Jan 2022
First submitted
15 Mar 2019
Last updated
1 Nov 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28753389

  • 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.

    PubMed 29595753

  • 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.

    PubMed 28982793

Questions about this trial

What is this clinical trial studying?

A study testing PHOTON COUNTING CT Scanner in people with Cancer and Inflammatory Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Difference in Diagnostic Image Quality Grading of Photon Counting CT vs Conventional CT Images. (time frame: 2 years and 3 months, 27 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03878134, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.

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Clinical Trial NCT03878134 | AzTrials