PET-CT Imaging With PCD-CT

April 2, 2026 updated by: Medical University of South Carolina

Advancing PET-CT Imaging With Photon Counting Detector CT

This pilot study evaluates the clinical utility of photon counting detector computed tomography (PCD-CT) in PET-CT imaging for head and neck cancer. Twenty adult patients undergoing standard-of-care PET-CT will also receive PCD-CT imaging. The study compares image quality and diagnostic confidence between conventional energy-integrating detector CT (EID-CT) and PCD-CT for attenuation correction and anatomical imaging.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Scheduled for or completed standard-of-care PET-CT of head and neck within ≤30 days

Exclusion Criteria:

  • Non-diagnostic PET-CT
  • Intervening therapy between scans
  • Iodinated contrast allergy
  • Renal insufficiency (GFR < 45)
  • Pregnancy
  • Gross motion artifacts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PET CT scan
To compare the image quality of PET images constructed using non-contrast PCD-CT image data to PET images constructed using conventional standard-of-care non-contrast EID-CT image data by performing a quantitative analysis of measurable image quality parameters.
Other: PCD-CT

A direct qualitative comparison of the subjective PET image quality will be performed.

Two blinded board-certified radiologists/nuclear medicine physicians will independently review PET images constructed using non-contrast PCD-CT data as well as PET images constructed using standard of care non-contrast EID-CT data in random order. Both raters will assess PET images subjectively regarding overall image quality using a five-point Likert scale. The rating will be defined as: (1) non-diagnostic - insufficient diagnostic confidence, (2) poor - low diagnostic confidence, (3) moderate - average diagnostic confidence; (4) good - high diagnostic confidence, and (5) excellent - full diagnostic confidence.
Other: PCD-CT
To compare the subjective image quality of PET images constructed using non-contrast PCD-CT image data to PET images constructed using conventional standard-of-care non-contrast EID-CT image data by performing a qualitative analysis of diagnostic confidence as determined by board-certified radiologists/nuclear medicine physicians during image review.
Other: PET CT
To compare the subjective image quality of PET images constructed using non-contrast PCD-CT image data to PET images constructed using conventional standard-of-care non-contrast EID-CT image data by performing a qualitative analysis of diagnostic confidence as determined by board-certified radiologists/nuclear medicine physicians during image review.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improve PET image w/ non-contrast PCD-CT data
Time Frame: 2 years
We expect that the subjective PET image quality will be improved by using non-contrast PCD-CT data for construction resulting in higher diagnostic confidence; demonstrating a case for the integration of PCD-CT into standard of care clinical PET-CT imaging in the future. There will be no direct benefit to study participants and the outcome will not be directly reported to the treatment team or patient and will not impact treatment or care received.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

Siemens Medical Solutions

Investigators

  • Principal Investigator: Kevin Horn, PhD, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00146888

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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