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Predicting Radiological Extranodal Extension in Oropharyngeal Carcinoma Patients Using AI (AI4rENE)

M

Maastricht Radiation Oncology

Status

Active, not recruiting

Conditions

Head and Neck Carcinoma

Study type

Observational

Funder types

Other

Identifiers

NCT05565313
W 22 03 00000 - P0471 V1.2

Details and patient eligibility

About

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

Full description

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

Enrollment

900 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)"

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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