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NCT Number: NCT05565313

Predicting Radiological Extranodal Extension in Oropharyngeal Carcinoma Patients Using AI

Development and validation of a model that predicts rENE from radiological imaging using annotated / labeled scans by means of deep learning

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

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About this study

Oropharyngeal squamous cell carcinoma (OPSCC) is a rare cancer (incidence ~700 per year in the Netherlands), originating in the middle part of the throat. In OPSCC, nodal status is an important prognostic factor for survival. In the clinical TNM (tumor node metastases) system, nodal status is mainly defined by the size, number and laterality of nodal metastases. In surgically treated patients the pathological TNM classification includes the presence of pathological extranodal extension (pENE). pENE is a predictor for poor outcome and also an indication for the addition of chemotherapy to postoperative radiation. However, most patients with OPSCC are treated non-surgically by means of radiation or chemoradiation and thus information about pENE is lacking. Recently, extranodal extension on diagnostic imaging has been associated with prognosis in OPSCC patients. It is anticipated that in the near future radiological ENE (rENE) may be included in the cTNM classification system for refinement of outcome prediction in patients with nodal disease. The diagnosis of rENE on radiological imaging is new and not trivial and we hypothesize that Artificial Intelligence (AI) may support the radiologist in detecting rENE. In this study we aim to develop and validate a model that predicts rENE from radiological imaging using annotated / labeled scans by means of deep learning

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)"

Treatment and study plan

Primary outcomes

  1. Prediction of rENE as labeled by the radiologist, using the AI model

    Time frame: Baseline

    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

  1. Overall Survival

    Time frame: 5 years

    Percentage of people who are alive five years after their diagnosis.

  2. Disease Free Survival

    Time frame: 5 years

    Percentage of people whp who are disease free five years after their diagnosis.

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Collaborators

  • Brigham and Women's Hospital
  • Princess Margaret Hospital, Canada

Registry information

Acronym: AI4rENE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2022
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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