Artificial Intelligence in Functional Imaging for Individualized Treatment of Head and Neck Squamous Cell Carcinoma Patients (KIVAL-KHT)

Charité University Medicine Berlin

Status: Enrolling

Conditions: HNSCC

Treatments: Other: Observation

Study type: Observational

Funder types: Other

Identifiers

NCT05192655

KIVAL-KHT

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

250 participants in 2 patient groups

HNSCC-patients treated with primary radio(chemo)therapy (R(C)T)

Description:

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.

Treatment:

Other: Observation

HNSCC-patients treated with primary surgery

Description:

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.

Treatment:

Other: Observation