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

NCT05192655 | Recruiting

• 1 other identifier: KIVAL-KHT
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HNSCC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Life Quality

  2 years

• Metastases-free survival

  2 years

• Toxicity of Treatment

  2 years

• Progression-free Survival

  2 years

Study Arms (2)

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

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

Interventions

Observation OTHER

Observation Study

HNSCC-patients treated with primary radio(chemo)therapy (R(C)T); HNSCC-patients treated with primary surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Helmholtz-Zentrum Dresden-Rossendorf: collaborator
• Max-Delbrück-Centrum Berlin: collaborator

Study Sites (1)

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

Berlin, 13353, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Analysis of genome sequences for risk stratification planned in further studies

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Observation

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Julian Weingärtner, Dr. med.

CONTACT

0030-450-657057; julian.weingaertner@charite.de

Sebastian Zschaeck, PD Dr. med.

CONTACT

sebastian.zschaeck@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at the Department of Radiooncology and Radiotherapy, Charité; BIH Charité Junior Digital Clinician Scientist

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 14, 2022
• Study Start: December 1, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)