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

HNSCC Clinical Trial

— KIVAL-KHT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192655
• Other study ID #: KIVAL-KHT
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 1, 2026

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Julian Weingärtner, Dr. med.
• Phone: 0030-450-657057
• Email: julian.weingaertner[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• HNSCC
• Squamous Cell Carcinoma of Head and Neck

Intervention

Other:
• Observation
Observation Study

Locations

Country	Name	City	State
Germany	Department of Radiooncology and Radiotherapy, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Helmholtz-Zentrum Dresden-Rossendorf, Max-Delbrück-Centrum Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Toxicity of Treatment	Collection of questionares regarding toxicity according to Common Toxicity Criteria (CTC) during routine follow-up check-ups	2 years
Secondary	Progression-free Survival	alternative for Overall survival; event in PFS defined as disease progression or death	2 years