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Active Not RecruitingNCT05565313

Predicting Radiological Extranodal Extension in Oropharyngeal Carcinoma Patients Using AI

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
900 (actual)
Sponsor
Maastricht Radiation Oncology · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Detailed 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

Conditions

Timeline

Start date
2022-03-22
Primary completion
2026-08-01
Completion
2026-08-01
First posted
2022-10-04
Last updated
2025-08-14

Locations

3 sites across 3 countries: United States, Canada, Netherlands

Source: ClinicalTrials.gov record NCT05565313. Inclusion in this directory is not an endorsement.

Predicting Radiological Extranodal Extension in Oropharyngeal Carcinoma Patients Using AI (NCT05565313) · Clinical Trials Directory