Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT05192655

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

Led by Charite University, Berlin, Germany · Updated on 2024-02-07

250

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

C

Charite University, Berlin, Germany

Lead Sponsor

H

Helmholtz-Zentrum Dresden-Rossendorf

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 years with diagnosed head and neck squamous cell carcinoma (HNSCC)
  • Patients attending Charité's Department of Radiooncology and Radiotherapy or Department of Oral and Maxillofacial Surgery
  • Patients planned for curative treatment with chemoradiation or primary surgery (or combined)
  • Patients who have had a pre-treatment 18F-Fluorodesoxyglucose (FDG) positron emission tomography (PET) scan
Not Eligible

You will not qualify if you...

  • Patients with HNSCC who cannot receive curative treatment
  • Patients planned for curative treatment but unable to have FDG PET imaging before treatment start
  • Patients who have withdrawn their consent to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Berlin, Germany, 13353

Actively Recruiting

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Research Team

J

Julian Weingärtner, Dr. med.

CONTACT

S

Sebastian Zschaeck, PD Dr. med.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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