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Enrolling by invitation Observational

p-PHOTOLARYNX- ANTHEM: Photon-Counting CT in Laryngeal Cancer Staging

NCT07603167 · tracked via the Priya Life Science Italy tracker
Sponsor
Humanitas University
Phase
Observational
Started
2025-05-16
Last updated
2026-05-22

Condition(s) studied

Laryngeal CancerLaryngeal Carcinoma

Investigational drug(s) / intervention(s)

Photon Counting Computed Tomography

Photon Counting Computed Tomography: Photon-Counting CT (PCCT) will be performed using the Siemens Healthineers NAEOTOM Alpha, the latest generation of CT technology and the first system to apply photon-counting detector technology to laryngeal imaging. Its CdTe detectors count individual photons and measure their energy, enabling true spectral imaging with ultra-high spatial resolution (voxel size down to 0.2 mm). Multi-energy maps significantly improve tissue differentiation, allowing clearer distinction between paraglottic fat, non-ossified thyroid cartilage, and tumor tissue. The technology also reduces artifacts and enhances contrast, enabling detailed evaluation of the laryngeal cartilages and paraglottic space.

Study summary

Laryngeal cancer can affect speaking, swallowing, and breathing. Treatment selection depends on accurately defining tumor spread within the larynx, particularly invasion of the paraglottic space, thyroid cartilage, and subglottic region. Understaging may lead to insufficient treatment and recurrence, whereas overstaging may result in unnecessarily aggressive surgery and impaired quality of life.

CT and MRI are routinely used for local staging, but both have limitations. Conventional CT may have limited soft-tissue and cartilage contrast, while MRI is more time-consuming, motion-sensitive, and not feasible in all patients. Photon-counting CT (PCCT) is a new CT technology offering higher spatial resolution, improved tissue contrast, and reconstructions at different energy levels.

This study evaluates whether PCCT performed during phonation, while the patient produces a sustained sound, can improve local staging of laryngeal cancer. Phonation may better separate and display laryngeal structures, improving detection of tumor extension.

The main hypothesis is that optimized phonation PCCT reconstructions can assess tumor spread more accurately than standard CT and may approach MRI performance. Participants undergo PCCT as part of routine preoperative imaging. Images are reconstructed using different settings and reviewed by radiologists for image quality and tumor extension. When surgery is performed, imaging findings are compared with surgical and histopathological results.

The study aims to identify the most accurate PCCT reconstruction strategy to support better treatment planning in laryngeal cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
1\. SELECTION CRITERIA Inclusion Criteria * Adults (≥18 years) * Biopsy-proven laryngeal cancer squamous cell carcinoma * Candidate for surgical staging able to undergo PCCT Exclusion criteria * Renal failure * Allergy to contrast medium * Refusal of informed consent * Lack of histopathologic confirmation * Histopathologic diagnosis of non laryngeal tumors * Poor image quality due to severe artifacts

Primary outcome measure(s)

  • Diagnostic Accuracy of Phonation Photon-Counting CT (PCCT) for Local Tumor Extension — From completion of baseline phonation PCCT imaging to histopathological correlation, assessed up to 12 weeks.
    Description: To evaluate the diagnostic accuracy of phonation PCCT in identifying paraglottic space invasion, thyroid cartilage invasion (including distinction between inner cortical erosion and full-thickness invasion), and subglottic extension, using surgical and histopathological findings as the reference standard.
  • Identification of the Optimal PCCT Reconstruction for Local Staging — From completion of baseline phonation PCCT imaging to histopathological correlation, assessed up to 12 weeks.
    To identify the best-performing phonation PCCT reconstruction (defined by VMI energy level and reconstruction kernel) for each anatomical target (paraglottic space, thyroid cartilage, subglottic space), based on diagnostic accuracy relative to histopathology.

Trial sites (1)

FacilityCityRegionStatus
Humanitas Research Hospital Rozzano Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07603167 on ClinicalTrials.gov ↗ ← All trials in Italy