p-PHOTOLARYNX- ANTHEM: Pilot Photon-Counting CT Evaluation of the Paraglottic Space and Cartilage Involvement in Laryngeal Cancer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. SELECTION CRITERIA
- •Inclusion Criteria
- •Adults (≥18 years)
- •Biopsy-proven laryngeal cancer squamous cell carcinoma
- •Candidate for surgical staging able to undergo PCCT
排除标准
- •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
研究者
Caterina Giannitto
Assistant Professor
Humanitas University