Clinical trial · Observational
Validation of High-resolution PET/CT for the Pretherapeutic Lymphnode Staging of Head/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)
In head and neck squamous cell carcinoma (HNSCC), the presence of lymph node metastases in addition to free resection margins following surgical resection of the primary tumor is an important prognostic factor, and may impact planning of surgery as well as of radiotherapy. Until now, imaging modalities including PET/CT and MRI did not allow to exclude especially small lymph node metastases. Compared to standard whole-body PET/CT acquisition techniques, high-resolution (HR) head and neck PET/CT acquisitions promise improved detection of lymph node metastases in head and neck squamous cell carcinoma (HNSCC). This prospective study aims to determine the sensitivity and specificity of lymph node staging with HR FDG-PET/CT in HNSCC by correlating PET/CT with histopathology after neck dissection. HR PET/CT may have a relevant impact on the therapeutic concept, and the planning and dose prescription of radiotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Otorhinolaryngeal Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- All patients
- description
- Patients with head and neck squamous cell carcinoma with advanced primary tumor stages (cT3 or cT4), clinical suspicion of cervical lymph node metastases, cervical lymph node metastasis of unknown primary tumor (CUP) or patients with tumor recurrence scheduled for neck dissection.
Primary outcomes (1)
- measure
- Diagnostic accuracy (sensitivity, specificity, accuracy, NPV und PPV) of HR PET/CT in comparison to the histopathological reference standard
- timeFrame
- At baseline
Secondary outcomes (2)
- measure
- Diagnostic accuracy (sensitivity, specificity, accuracy, NPV und PPV) of PET/CT according to the size of lymph node metastases
- timeFrame
- At baseline
- measure
- Number of patients where PET/CT results in a change of gross tumor volume (GTV) and/or dose prescription
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Head and neck squamous cell carcinoma (HNSCC), fulfilling one or more of the following criteria: * Advanced primary tumor stage (cT3 or cT4) * Clinical suspicion of neck lymph node metastases * Cervical lymph node metastases of unknown primary tumor (CUP) * Tumor recurrence * Mature adult * Written informed consent Exclusion Criteria: * Inoperability * Histologically verified cervical lymph node metastases of other tumors
References
Publications (0)
Data not yet available