Predicting Radiological Extranodal Extension in Oropharyngeal Carcinoma Patients Using AI

NCT05565313 | Active Not Recruiting

• 1 other identifier: W 22 03 00000 - P0471 V1.2
• Study Type: observational
• Target: 900
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline

Secondary Outcomes (2)

• Overall Survival

  5 years

• Disease Free Survival

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria: * Non-metastatic (M0) node-positive HPV+ and HPV- (human papilloma virus) oropharyngeal carcinoma * Treated between 2008 to 2019 * Curative intent * Radiation only or concurrent chemoradiation * Modern treatment modality: IMRT / VMAT (Intensity Modulated RadioTherapy / Volumetric-Modulated Arc Therapy) * diagnostic/staging image scanning protocols available (contrast-enhanced CT with 2-3 mm slice thickness and/or MR (magnetic resonance) 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)"

You may qualify if:

• 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)

You may not qualify if:

• 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)"

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Brigham and Women's Hospital: collaborator
• Princess Margaret Hospital, Canada: collaborator

Study Sites (3)

Harvard Medical School and clinical faculty at Dana-Farber Cancer Institute/Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Maastro

Maastricht, Limburg, 6229 ET, Netherlands

Location

Study Officials

• Frank Hoebers, PhD

  Maastro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 4, 2022
• Study Start: March 22, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication

Locations

US (1); CA (1); NL (1)