Clinical trial · Observational
Predicting Radiological Extranodal Extension in Oropharyngeal Carcinoma Patients Using AI
NCT05565313CI-TRIAL-00093621AI4rENEactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
Development and validation of a model that predicts rENE from radiological imaging using annotated / labeled scans by means of deep learning
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 |
|---|---|---|---|
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prediction of rENE as labeled by the radiologist, using the AI model
- timeFrame
- Baseline
- description
- The performance of the model will be evaluated in terms of discrimination through the Harrell's C-index and the area (AUC) under the receiver operator curve (ROC) in predicting rENE.
Secondary outcomes (2)
- measure
- Overall Survival
- timeFrame
- 5 years
- description
- Percentage of people who are alive five years after their diagnosis.
- measure
- Disease Free Survival
- timeFrame
- 5 years
- description
- Percentage of people whp who are disease free five years after their diagnosis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Non-metastatic (M0) node-positive HPV+ and HPV- oropharyngeal carcinoma * Treated between 2008 to 2019 * Curative intent * Radiation only or concurrent chemoradiation * Modern treatment modality: IMRT / VMAT * diagnostic/staging image scanning protocols available (contrast-enhanced CT with 2-3 mm slice thickness and/or MR with 3 mm slice thickness) Exclusion criteria: * removal of lymph node (LN) (excisional biopsy or neck dissection \[ND\]) prior to staging CT/MR scan * no available imaging within 2 months prior to radiotherapy (RT)"
References
Publications (0)
Data not yet available
No reference posted for this study.