Department of Radiooncology and Radiotherapy, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, 13353, Germany
Location status: Recruiting
NCT Number: NCT05192655
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Berlin, 13353, Germany
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Observation Study
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 2 years
Collection of questionares regarding toxicity according to Common Toxicity Criteria (CTC) during routine follow-up check-ups
Time frame: 2 years
alternative for Overall survival; event in PFS defined as disease progression or death
Contact information is provided by the study sponsor or research team.
Julian Weingärtner, Dr. med.
CONTACT
Sebastian Zschaeck, PD Dr. med.
CONTACT
Charite University, Berlin, Germany
Other
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
Acronym: KIVAL-KHT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04722523
Carcinoma, Carcinoma, Squamous Cell
Basking Ridge, New Jersey, United States
View Trial DetailsNCT07686575
Carcinoma, Carcinoma, Squamous Cell
Guangzhou, Guangdong, China
View Trial DetailsNCT06819228
Carcinoma, Carcinoma, Squamous Cell
Nashville, Tennessee, United States
View Trial DetailsNCT05581004
Adenocarcinoma, Carcinoma
San Francisco, California, United States
View Trial Details