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NCT Number: NCT05192655

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Radiooncology and Radiotherapy, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, 13353, Germany

Location status: Recruiting

Location contact

Julian Weingärtner, PhD

CONTACT

[email protected]

030450657057

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

Observation Study

Primary outcomes

  1. Locoregional Control

    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

Secondary outcomes

  1. Life Quality

    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)

  2. Metastases-free survival

    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)

  3. Toxicity of Treatment

    Time frame: 2 years

    Collection of questionares regarding toxicity according to Common Toxicity Criteria (CTC) during routine follow-up check-ups

  4. Progression-free Survival

    Time frame: 2 years

    alternative for Overall survival; event in PFS defined as disease progression or death

Study contacts

Contact information is provided by the study sponsor or research team.

Julian Weingärtner, Dr. med.

CONTACT

[email protected]

0030-450-657057

Sebastian Zschaeck, PD Dr. med.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Helmholtz-Zentrum Dresden-Rossendorf
  • Max-Delbrück-Centrum Berlin

Registry information

Official study 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

Acronym: KIVAL-KHT

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jan 14, 2022
Registry last updated
Feb 7, 2024

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.

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