NCT07242690

Brief Summary

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.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

November 17, 2025

Last Update Submit

April 2, 2026

Conditions

Head and Neck Cancer (H&N)

Outcome Measures

Primary Outcomes (1)

  • improve PET image w/ non-contrast PCD-CT data

    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

Study Arms (2)

PET CT scan

OTHER

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

PCD-CT

OTHER

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

Interventions

PCD-CTOTHER

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.

PET CT scan
PET CTOTHER

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.

PCD-CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Kevin Horn, PhD, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

US(1)