Artificial Intelligence in Functional Imaging for Individualized Treatment of Head and Neck Squamous Cell Carcinoma Patients

Recruiting

• Conditions: HNSCC
• Interventions: Other: Observation

• Registration Number: NCT05192655
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The two curative treatment modalities for patients with HNSCC - primary chemoradiation (CRT) or primary surgery (often combined with postoperative (C)RT) - are both associated with serious side effects for which reason further stratification, optimization and personalization of treatment is urgently needed. As novel quantitative image analyses are a promising tool for further risk stratification, the investigators training a three-dimensional Convolutional Neural Network on 18F-Fluorodesoxyglucose (FDG) positron emission tomography (PET) imaging and clinical / histopathological data of a multicentric, retrospective cohort of 1200 patients treated with primary CRT and 800 patients treated with primary surgery at Charité and cooperation institutes in order to predict individual treatment-specific outcomes and identify patients with excellent outcome after primary CRT or primary surgery or unfavorable outcome for both. The trained algorithm of the artificial intelligence will be validated in a prospective trial to see if predicted loco-regional control and recommended treatment strategies are reliable. In total 250 curative HNSCC patients, treated with CRT or primary surgery, will be enrolled on this prospective validation trial with observational character, while biomarker, clinical and FDG-PET data are collected from these patients and follow-up visits will be concluded.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• All patients older than 18 years with diagnosed HNSCC, attending the Department of Radiooncology and Radiotherapy or the Department of Oral and Maxillofacial Surgery at Charité for a treatment with curative intension ( R(C)T or primary surgery / combined).
• All patients received as pretherapeutic diagnostic method a 18F-Fluorodesoxyglucose (FDG) positron emission tomography (PET) imaging

Exclusion Criteria

• Patients with HNSCC who cannot be treated in a curative approach
• Patients with HNSCC treated in a curative approach but unable to receive FDG PET imaging before start of treatment
• Data from patients who have withdrawn their study consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HNSCC-patients treated with primary radio(chemo)therapy (R(C)T)	Observation	Patients, older than 18 years, with diagnosed HNSCC, attending the Department of Radiooncology and Radiotherapy at Charité for a treatment with curative intension (R(C)T) . All patients received as pretherapeutic diagnostic method a 18F-Fluorodesoxyglucose (FDG) positron emission tomography (PET) imaging.
HNSCC-patients treated with primary surgery	Observation	Patients, older than 18 years, with diagnosed HNSCC, attending the Department of Oral and Maxillofacial Surgery or ENT Department at Charité for a treatment with curative intension ( primary surgery +/- combined with adjuvant (R(C)T)). All patients received as pretherapeutic diagnostic method a 18F-Fluorodesoxyglucose (FDG) positron emission tomography (PET) imaging.

Primary Outcome Measures

Name	Time	Method
Locoregional Control	2 years	Freedom from local progression within the first two years after treatment. Failure of locoregional control is defined as relapse of tumor confirmed by biopsy or if biopsy is inadequate or not feasible, consisting clear image morphology (MRI / CT / PET) during routine follow-up check-ups

Secondary Outcome Measures

Name	Time	Method
Life Quality	2 years	Collection of questionares regarding life quality before treatment and during routine follow-up check-ups after treatment regarding to the European Quality of Life Instrument (EURO-QOL)
Metastases-free survival	2 years	Freedom of Metastasis within the first two years after treatment during routine follow-up check-ups; Metastasis must be confirmed by biopsy or clear image morphology if a biopsy is not feasible (MRI / CT / PET)
Toxicity of Treatment	2 years	Collection of questionares regarding toxicity according to Common Toxicity Criteria (CTC) during routine follow-up check-ups
Progression-free Survival	2 years	alternative for Overall survival; event in PFS defined as disease progression or death

Trial Locations

Locations (1)

Department of Radiooncology and Radiotherapy, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum; 🇩🇪 Berlin, Germany