Clinical trial · Observational
Radiomics Model for Assessing Lymph Node Status in cN0 Patients withHNSCC
CT-based Radiomics Predicts Occult LNM and Uncovers Immune Microenvironment of Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Occult lymph node metastasis (LNM) remains one of the most critical and challenging aspects of managing head and neck squamous cell carcinoma (HNSCC). Defined as the presence of metastatic disease in lymph nodes that are clinically undetectable through routine imaging or physical examination, occult LNM has profound implications for treatment planning, prognosis, and overall patient management. In HNSCC, accurate detection and prediction of occult LNM are crucial as they significantly influence decisions regarding the extent of neck dissection, the need for adjuvant therapies, and the overall therapeutic strategy. Undiagnosed or underestimated LNM can result in inadequate treatment, increasing the risk of locoregional recurrence and poor survival outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Training set
- description
- The training set comprised approximately 500 cN0 patients diagnosed with head and neck squamous cell carcinoma (HNSCC), including approximately 150 patients with lymph node metastasis and approximately 350 patients without metastasis. All patients underwent preoperative contrast-enhanced CT scans.
- interventionNames
- Diagnostic Test: AI
- label
- internal test set
- description
- The internal validation set included approximately 150 patients, randomly selected from the training cohort. This set was used for model evaluation and tuning.
- interventionNames
- Diagnostic Test: AI
- label
- external test set
- description
- The external validation set consisted of approximately 200 patients with HNSCC. These patients were enrolled from other centers, and their data included preoperative contrast-enhanced CT images. This independent dataset was used to assess the generalizability of the radiomics model.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: 1. Availability of complete clinical data; 2. Diagnosis of laryngeal squamous cell carcinoma confirmed by surgery or biopsy; 3. CT contrast-enhanced examination performed within two weeks prior to surgery. 4. All patients underwent neck lymph node dissection surgery. Exclusion Criteria: 1. Patients who received other treatments before surgery; 2. CT images with significant artifacts; 3. Patients with tumor recurrence.
References
Publications (0)
Data not yet available