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

NCT07603167 | Enrolling By Invitation DMC

• 1 other identifier: 4981
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laryngeal Cancer; Laryngeal Carcinoma

Keywords

Larynx; Photon Counting Computed Tomography

Outcome Measures

Primary Outcomes (2)

• Diagnostic Accuracy of Phonation Photon-Counting CT (PCCT) for Local Tumor Extension

  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.

  From completion of baseline phonation PCCT imaging to histopathological correlation, assessed up to 12 weeks.

• Identification of the Optimal PCCT Reconstruction for Local Staging

  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.

  From completion of baseline phonation PCCT imaging to histopathological correlation, assessed up to 12 weeks.

Secondary Outcomes (10)

• Robustness of Local Staging Across PCCT Reconstructions

  From completion of baseline phonation PCCT imaging to histopathological correlation, assessed up to 12 weeks.

• Interobserver Agreement for Qualitative and Staging Assessments

  From completion of baseline phonation PCCT imaging to histopathological correlation, assessed up to 12 weeks.

• Tumor attenuation

  At baseline imaging, before surgery.

• Image noise

  At baseline imaging, before surgery.

• Signal-to-noise ratio (SNR)

  At baseline imaging, before surgery.

Study Arms (1)

Biopsy-Proven Laryngeal Squamous Cell Carcinoma Patients

A total of sixty patients, with biopsy-proven and clinical laryngeal squamous cell carcinoma

Diagnostic Test: Photon Counting Computed Tomography

Interventions

Photon Counting Computed Tomography DIAGNOSTIC_TEST

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.

Biopsy-Proven Laryngeal Squamous Cell Carcinoma Patients

Eligibility Criteria

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

Study Population

A total of sixty patients, with biopsy-proven laryngeal squamous cell carcinoma will be enrolled in the study.

You may qualify if:

• Adults (≥18 years)
• Biopsy-proven laryngeal cancer squamous cell carcinoma
• Candidate for surgical staging able to undergo PCCT

You may not qualify if:

• 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

Sponsors & Collaborators

• Humanitas University: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, 20089, Italy

Location

Related Publications (10)

• Kuno H, Sakamaki K, Fujii S, Sekiya K, Otani K, Hayashi R, Yamanaka T, Sakai O, Kusumoto M. Comparison of MR Imaging and Dual-Energy CT for the Evaluation of Cartilage Invasion by Laryngeal and Hypopharyngeal Squamous Cell Carcinoma. AJNR Am J Neuroradiol. 2018 Mar;39(3):524-531. doi: 10.3174/ajnr.A5530. Epub 2018 Jan 25.

  PMID: 29371253 BACKGROUND

• Preda L, Conte G, Bonello L, Giannitto C, Tagliabue E, Raimondi S, Ansarin M, De Benedetto L, Cattaneo A, Maffini F, Bellomi M. Diagnostic accuracy of surface coil MRI in assessing cartilaginous invasion in laryngeal tumours: Do we need contrast-agent administration? Eur Radiol. 2017 Nov;27(11):4690-4698. doi: 10.1007/s00330-017-4840-x. Epub 2017 May 5.

  PMID: 28477165 BACKGROUND

• Becker M, Zbaren P, Casselman JW, Kohler R, Dulguerov P, Becker CD. Neoplastic invasion of laryngeal cartilage: reassessment of criteria for diagnosis at MR imaging. Radiology. 2008 Nov;249(2):551-9. doi: 10.1148/radiol.2492072183.

  PMID: 18936314 BACKGROUND

• Yu Z, Leng S, Kappler S, Hahn K, Li Z, Halaweish AF, Henning A, McCollough CH. Noise performance of low-dose CT: comparison between an energy integrating detector and a photon counting detector using a whole-body research photon counting CT scanner. J Med Imaging (Bellingham). 2016 Oct;3(4):043503. doi: 10.1117/1.JMI.3.4.043503. Epub 2016 Dec 14.

  PMID: 28018936 BACKGROUND

• Becker M, Zbären P, Casselman JW, et al. MRI in the Preoperative Staging of Laryngeal Cancer. AJNR. 2010;31(4):592-599. doi:10.3174/ajnr.A1912

  BACKGROUND

• Castelijns JA, van den Brekel MW. Imaging of Laryngeal Cancer. Eur J Radiol. 2008;66(3):501-517. doi:10.1016/j.ejrad.2008.01.046

  BACKGROUND

• Leng S, Bruesewitz M, Tao S, et al. Photon-Counting CT: Impact on Noise, Spatial Resolution, and Image Quality. Radiology. 2020;297(3):738-746. doi:10.1148/radiol.2020201407

  BACKGROUND

• Li H, Yadava G, Procopiou M, et al. Photon-Counting Detector CT: Clinical Applications of an Emerging Technology. Radiographics. 2022;42(5):1439-1456. doi:10.1148/rg.220014

  BACKGROUND

• Hermans R, Boomgaert L, Cockmartin L, Binst J, De Stefanis R, Bosmans H. Photon-counting CT allows better visualization of temporal bone structures in comparison with current generation multi-detector CT. Insights Imaging. 2023 Jul 3;14(1):112. doi: 10.1186/s13244-023-01467-w.

  PMID: 37395919 BACKGROUND

• Benson JC, Campeau NG, Diehn FE, Lane JI, Leng S, Moonis G; ASHNR Research Committee. Photon-Counting CT in the Head and Neck: Current Applications and Future Prospects. AJNR Am J Neuroradiol. 2024 Aug 9;45(8):1000-1005. doi: 10.3174/ajnr.A8265.

  PMID: 38964861 BACKGROUND

MeSH Terms

Conditions

Laryngeal Neoplasms; Laryngeal Diseases

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: May 22, 2026
• Study Start: May 16, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

IT (1)