Clinical trial NCT05192655: Artificial Intelligence in Functional Imaging for Individualized Treatment of Head and Neck Squamous Cell Carcinoma Patients
Official title: Künstliche Intelligenz (KI) in Der Funktionellen Bildgebung Zur Individualisierten Behandlung Von Kopf-Hals-Plattenepithelkarzinom-Patienten Artificial Intelligence in Functional Imaging for Individualized Treatment of Head and Neck Squamous Cell Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HNSCC
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Helmholtz-Zentrum Dresden-Rossendorf
name: Max-Delbrück-Centrum Berlin
First posted: 2022-01-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 ( primary R(C)T or primary surgery / combined).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Locoregional Control
timeFrame: 2 years
Secondary outcomes:
measure: Life Quality
timeFrame: 2 years
measure: Metastases-free survival
timeFrame: 2 years
measure: Toxicity of Treatment
timeFrame: 2 years
measure: Progression-free Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Radiooncology and Radiotherapy, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Study officials:
References: