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

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

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.

Study Overview

• Status: Recruiting
• Conditions: HNSCC
• Intervention / Treatment: Other: Observation

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Julian Weingärtner, Dr. med.; Phone Number: 0030-450-657057; Email: julian.weingaertner@charite.de
• Study Contact Backup: Name: Sebastian Zschaeck, PD Dr. med.; Email: sebastian.zschaeck@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Department of Radiooncology and Radiotherapy, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
    • Contact: Julian Weingärtner, PhD; Phone Number: 030450657057; Email: julian.weingaertner@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HNSCC-patients treated with primary radio(chemo)therapy (R(C)T); 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.	Other: Observation; Observation Study
HNSCC-patients treated with primary surgery; 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.	Other: Observation; Observation Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locoregional Control	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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life Quality	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)	2 years
Metastases-free survival	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)	2 years
Toxicity of Treatment	Collection of questionares regarding toxicity according to Common Toxicity Criteria (CTC) during routine follow-up check-ups	2 years
Progression-free Survival	alternative for Overall survival; event in PFS defined as disease progression or death	2 years

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Helmholtz-Zentrum Dresden-Rossendorf; Max-Delbrück-Centrum Berlin

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: KIVAL-KHT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In order to enable a replication by independent researchers, the AI technology and algorithm will be made publicly accessible. Patients of the prospective imaging trial have the option to consent to the pseudonymized publication of their imaging data, this enables upload of the dataset to public image repositories. In this way the reproduction and thus verification of the results of the prospective part will be possible. Imaging protocols, analyzed scans, details about the extracted features and of the modelling and segmentation methodology will be disclosed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No