Laryngeal CancerH&NRAD-2025-01NCT07603167
p-PHOTOLARYNX- ANTHEM: Photon-Counting CT in Laryngeal Cancer Staging
An observational study of Laryngeal Cancer and Laryngeal Carcinoma, run by Humanitas University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Cancer, Laryngeal Carcinoma
- What is being tested?
- Photon Counting Computed Tomography
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 16 May 2025to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: A total of sixty patients, with biopsy-proven laryngeal squamous cell carcinoma will be enrolled in the study.
Who may be able to join
- Adults (≥18 years)
- Biopsy-proven laryngeal cancer squamous cell carcinoma
- Candidate for surgical staging able to undergo PCCT
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: p-PHOTOLARYNX- ANTHEM: Pilot Photon-Counting CT Evaluation of the Paraglottic Space and Cartilage Involvement in Laryngeal Cancer
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.
Read more
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.
Read the detailed description
This is a prospective, single-center observational imaging study designed to evaluate the diagnostic performance of photon-counting computed tomography (PCCT) acquired during phonation for local staging of biopsy-proven laryngeal squamous cell carcinoma.
Study Overview and Imaging Workflow
Eligible adult patients with histologically confirmed laryngeal squamous cell carcinoma referred for preoperative imaging undergo contrast-enhanced PCCT as part of routine clinical work-up. PCCT examinations are performed on a dedicated photon-counting CT system using a standardized acquisition protocol optimized for ultra-high-resolution imaging of the larynx during phonation. Imaging is acquired in the venous phase under sustained vocalization to enhance functional and morphological assessment of glottic and subglottic structures.
For each acquisition, multiple reconstructions are generated, including ultra-high-resolution virtual monoenergetic images (VMIs) at predefined energy levels and different reconstruction kernels. A 70-keV reconstruction with standard slice thickness is included as an energy-integrating detector (EID)-CT-like reference. When available, previously acquired conventional CT and/or MRI performed as part of standard care are included for comparative analysis. Surgical histopathology serves as the reference standard for local tumor extension.
Qualitative Image Assessment
Qualitative analysis is restricted to phonation acquisitions to maximize clinical relevance and reduce reader burden. Four expert head and neck radiologists independently review anonymized and randomized datasets, blinded to reconstruction parameters. For each dataset, readers assign a qualitative diagnostic quality score using a five-point Likert scale and evaluate tumor extension into the paraglottic space, thyroid cartilage (with distinction between inner cortical erosion and full-thickness invasion), and subglottic space using predefined ordinal scoring systems. Multiplanar reformations aligned with the glottic plane and axis are mandatorily assessed as part of each dataset.
Quantitative Image Assessment
Quantitative analysis is performed by two independent observers on a dedicated workstation. Standardized regions of interest (ROIs) are placed in the primary tumor, adjacent non-tumoral laryngeal tissues, subcutaneous fat (for noise estimation), and the common carotid artery (vascular reference). ROIs are defined on a representative axial slice and propagated across all reconstructions to ensure measurement consistency. Quantitative metrics include attenuation values, image noise, signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR).
Data Management and Quality Assurance
Data are collected using structured electronic case report forms (eCRFs) derived from hospital source documents. All imaging data are anonymized prior to analysis. Quality assurance procedures are based on written standard operating procedures at the sponsor site and include verification of data completeness, internal consistency checks, and cross-validation of imaging assessments with source data (radiology reports, surgical and pathology records). Access to source data is permitted for authorized personnel in accordance with Good Clinical Practice and data protection regulations.
Statistical Analysis Plan
Given the exploratory, pilot nature of the study, the planned sample size of 60 patients is based on feasibility and the need to support descriptive and comparative multi-dataset, multi-reader analyses rather than formal hypothesis testing. Quantitative variables are summarized using appropriate descriptive statistics based on data distribution. Interobserver agreement is assessed using intraclass correlation coefficients for quantitative measures and Fleiss' kappa for ordinal qualitative scores.
The effects of VMI energy level and reconstruction kernel on quantitative and qualitative outcomes are evaluated using mixed-effects models accounting for repeated measures within patients and readers. Diagnostic performance of PCCT, and where available conventional CT and MRI, is assessed using sensitivity, specificity, predictive values, and receiver operating characteristic analysis with histopathology as the reference standard. Adjustment for multiple comparisons is applied when appropriate.
Handling of Missing Data
Missing or non-evaluable data (e.g., due to severe artifacts or unavailable histopathology) are documented explicitly. Analyses are primarily conducted on available data without imputation, and sensitivity analyses may be performed to assess the impact of missing values.
Ethical and Operational Considerations
The study does not modify standard clinical management. No study-specific adverse events are anticipated. All procedures comply with the Declaration of Helsinki, Good Clinical Practice, and applicable regulatory requirements. Written informed consent is obtained prior to participation.
- Conditions
- Laryngeal Cancer, Laryngeal Carcinoma
- Being tested
- Photon Counting Computed Tomography
- Keywords
- Larynx, Photon Counting Computed Tomography
- Medical subject headings
- Laryngeal Neoplasms, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon Counting Computed TomographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Biopsy-Proven Laryngeal Squamous Cell Carcinoma Patients | A total of sixty patients, with biopsy-proven and clinical laryngeal squamous cell carcinoma Receives: Diagnostic Test: Photon Counting Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
To assess variability in local staging classification (paraglottic space invasion, cartilage involvement, subglottic extension) across different phonation PCCT reconstructions, including staging upgrades or downgrades between datasets.
Measured: From completion of baseline phonation PCCT imaging to histopathological correlation, assessed up to 12 weeks.
Interobserver Agreement for Qualitative and Staging Assessments
To evaluate interobserver reproducibility among readers for qualitative diagnostic quality scores and ordinal staging assessments of paraglottic space invasion, cartilage involvement, and subglottic extension.
.
Measured: From completion of baseline phonation PCCT imaging to histopathological correlation, assessed up to 12 weeks.
Tumor attenuation
Mean attenuation measured in Hounsfield Units (HU) within tumor regions of interest.
Measured: At baseline imaging, before surgery.
Image noise
Image noise defined as the standard deviation of attenuation measured in a homogeneous region (e.g., subcutaneous fat).
Measured: At baseline imaging, before surgery.
Signal-to-noise ratio (SNR)
Signal-to-noise ratio calculated as mean tumor attenuation divided by image noise.
Measured: At baseline imaging, before surgery.
Contrast-to-noise ratio (CNR)
Contrast-to-noise ratio calculated as the difference in attenuation between tumor and reference tissue divided by image noise.
Measured: At baseline imaging, before surgery.
CT dose index volume (CTDIvol)
Volume CT dose index measured in milligray (mGy)
Measured: At baseline imaging, before surgery.
Dose-length product (DLP)
Dose-length product measured in milligray-centimeters (mGy·cm).
Measured: At baseline imaging, before surgery.
Effective dose
Estimated effective radiation dose expressed in millisieverts (mSv).
Measured: At baseline imaging, before surgery.
Comparison of PCCT with Conventional CT and MRI
To compare the diagnostic performance of phonation PCCT with conventional energy-integrating detector CT and MRI, when available, using histopathology as the reference standard.
Measured: From completion of phonation PCCT imaging to completion of multimodality image review and histopathological correlation, assessed up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start16 May 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Laryngeal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanitas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caterina Giannitto, Humanitas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603167
- Sponsor's protocol ID
- 4981
- Acronym
- H&NRAD-2025-01
- Status last verified
- May 2026
- First submitted
- 27 Dec 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At the time of registration, no final decision has been made regarding sharing of individual participant data. Any future data sharing would be subject to ethical approval, data protection regulations, and appropriate data use agreements.
Publications
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.
PubMed 29371253Preda 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.
PubMed 28477165Becker 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.
PubMed 18936314Yu 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.
PubMed 28018936Becker 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
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
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
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
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.
PubMed 37395919Benson 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.
PubMed 38964861
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- p-PHOTOLARYNX- ANTHEM: Pilot Photon-Counting CT Evaluation of the Paraglottic Space and Cartilage Involvement in Laryngeal Cancer
- ClinicalTrials.gov ID
- NCT07603167
- Acronym / sponsor ID
- H&NRAD-2025-01 / 4981
- Conditions
- Laryngeal Cancer, Laryngeal Carcinoma
- Keywords
- Larynx, Photon Counting Computed Tomography
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Humanitas UniversityUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-center observational imaging study designed to evaluate the diagnostic performance of photon-counting computed tomography (PCCT) acquired during phonation for local staging of biopsy-proven laryngeal squamous cell carcinoma.
Study Overview and Imaging Workflow
Eligible adult patients with histologically confirmed laryngeal squamous cell carcinoma referred for preoperative imaging undergo contrast-enhanced PCCT as part of routine clinical work-up. PCCT examinations are performed on a dedicated photon-counting CT system using a standardized acquisition protocol optimized for ultra-high-resolution imaging of the larynx during phonation. Imaging is acquired in the venous phase under sustained vocalization to enhance functional and morphological assessment of glottic and subglottic structures.
For each acquisition, multiple reconstructions are generated, including ultra-high-resolution virtual monoenergetic images (VMIs) at predefined energy levels and different reconstruction kernels. A 70-keV reconstruction with standard slice thickness is included as an energy-integrating detector (EID)-CT-like reference. When available, previously acquired conventional CT and/or MRI performed as part of standard care are included for comparative analysis. Surgical histopathology serves as the reference standard for local tumor extension.
Qualitative Image Assessment
Qualitative analysis is restricted to phonation acquisitions to maximize clinical relevance and reduce reader burden. Four expert head and neck radiologists independently review anonymized and randomized datasets, blinded to reconstruction parameters. For each dataset, readers assign a qualitative diagnostic quality score using a five-point Likert scale and evaluate tumor extension into the paraglottic space, thyroid cartilage (with distinction between inner cortical erosion and full-thickness invasion), and subglottic space using predefined ordinal scoring systems. Multiplanar reformations aligned with the glottic plane and axis are mandatorily assessed as part of each dataset.
Quantitative Image Assessment
Quantitative analysis is performed by two independent observers on a dedicated workstation. Standardized regions of interest (ROIs) are placed in the primary tumor, adjacent non-tumoral laryngeal tissues, subcutaneous fat (for noise estimation), and the common carotid artery (vascular reference). ROIs are defined on a representative axial slice and propagated across all reconstructions to ensure measurement consistency. Quantitative metrics include attenuation values, image noise, signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR).
Data Management and Quality Assurance
Data are collected using structured electronic case report forms (eCRFs) derived from hospital source documents. All imaging data are anonymized prior to analysis. Quality assurance procedures are based on written standard operating procedures at the sponsor site and include verification of data completeness, internal consistency checks, and cross-validation of imaging assessments with source data (radiology reports, surgical and pathology records). Access to source data is permitted for authorized personnel in accordance with Good Clinical Practice and data protection regulations.
Statistical Analysis Plan
Given the exploratory, pilot nature of the study, the planned sample size of 60 patients is based on feasibility and the need to support descriptive and comparative multi-dataset, multi-reader analyses rather than formal hypothesis testing. Quantitative variables are summarized using appropriate descriptive statistics based on data distribution. Interobserver agreement is assessed using intraclass correlation coefficients for quantitative measures and Fleiss' kappa for ordinal qualitative scores.
The effects of VMI energy level and reconstruction kernel on quantitative and qualitative outcomes are evaluated using mixed-effects models accounting for repeated measures within patients and readers. Diagnostic performance of PCCT, and where available conventional CT and MRI, is assessed using sensitivity, specificity, predictive values, and receiver operating characteristic analysis with histopathology as the reference standard. Adjustment for multiple comparisons is applied when appropriate.
Handling of Missing Data
Missing or non-evaluable data (e.g., due to severe artifacts or unavailable histopathology) are documented explicitly. Analyses are primarily conducted on available data without imputation, and sensitivity analyses may be performed to assess the impact of missing values.
Ethical and Operational Considerations
The study does not modify standard clinical management. No study-specific adverse events are anticipated. All procedures comply with the Declaration of Helsinki, Good Clinical Practice, and applicable regulatory requirements. Written informed consent is obtained prior to participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy-Proven Laryngeal Squamous Cell Carcinoma Patients | – | Diagnostic Test: Photon Counting Computed TomographyA total of sixty patients, with biopsy-proven and clinical laryngeal squamous cell carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of sixty patients, with biopsy-proven laryngeal squamous cell carcinoma will be enrolled in the study.
Key inclusion criteria (3 listed)
- Adults (≥18 years)
- Biopsy-proven laryngeal cancer squamous cell carcinoma
- Candidate for surgical staging able to undergo PCCT
Key exclusion criteria (6 listed)
- Renal failure
- Allergy to contrast medium
- Refusal of informed consent
- Lack of histopathologic confirmation
- Histopathologic diagnosis of non laryngeal tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photon Counting Computed TomographyPhoton-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. | Diagnostic test | Biopsy-Proven Laryngeal Squamous Cell Carcinoma Patients |
Primary outcome
Diagnostic Accuracy of Phonation Photon-Counting CT (PCCT) for Local Tumor Extension
Time frame: 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
Time frame: 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.
10 secondary outcomes
Robustness of Local Staging Across PCCT Reconstructions
Time frame: From completion of baseline phonation PCCT imaging to histopathological correlation, assessed up to 12 weeks.
Interobserver Agreement for Qualitative and Staging Assessments
Time frame: From completion of baseline phonation PCCT imaging to histopathological correlation, assessed up to 12 weeks.
Tumor attenuation
Time frame: At baseline imaging, before surgery.
Image noise
Time frame: At baseline imaging, before surgery.
Signal-to-noise ratio (SNR)
Time frame: At baseline imaging, before surgery.
Contrast-to-noise ratio (CNR)
Time frame: At baseline imaging, before surgery.
CT dose index volume (CTDIvol)
Time frame: At baseline imaging, before surgery.
Dose-length product (DLP)
Time frame: At baseline imaging, before surgery.
Effective dose
Time frame: At baseline imaging, before surgery.
Comparison of PCCT with Conventional CT and MRI
Time frame: From completion of phonation PCCT imaging to completion of multimodality image review and histopathological correlation, assessed up to 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 29371253Kuno 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.
- Background: PubMed 28477165Preda 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.
- Background: PubMed 18936314Becker 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.
- Background: PubMed 28018936Yu 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.
- BackgroundBecker 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
- BackgroundCastelijns 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
- BackgroundLeng 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
- BackgroundLi 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: PubMed 37395919Hermans 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.
- Background: PubMed 38964861Benson 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.
- Individual participant dataSharing planned: Undecided. At the time of registration, no final decision has been made regarding sharing of individual participant data. Any future data sharing would be subject to ethical approval, data protection regulations, and appropriate data use agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngeal Cancer and Laryngeal Carcinoma, run by Humanitas University at 1 site in Italy.
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 6 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: enrolling by invitation, as of the sponsor's last update on 22 May 2026. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic Accuracy of Phonation Photon-Counting CT (PCCT) for Local Tumor Extension (time frame: From completion of baseline phonation PCCT imaging to histopathological correlation, assessed up to 12 weeks.). The study lists 2 primary outcomes in all. 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 NCT07603167, which also lists 10 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 22 May 2026.