Prospective observational study on the clinical relevance of the combined PET / MR examination in pediatric oncology

• Conditions: C00-C97; Malignant neoplasms

• Registration Number: DRKS00024123
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Children or adolescents <18 years of age for whom the PET/MRI examination is carried out for the following indications:
• PET/MRI examination for clinical indication for tumor search (e.g. FUO)
• PET/MRI examination for clinical indication for primary staging or re-staging in Hodgin's lymphoma
• PET/MRI examination for clinical indication for primary staging or re-staging after therapy in histologically proven, advanced malignant solid tumors (e.g. bone and soft tissue tumors, CNS tumors, neuroblastomas, germ cell tumors)
• PET/MRI examination in the case of unclear or inconspicuous imaging for therapy planning (OP, RT, Ctx) and prognosis stratification
• PET/MRI examination for re-staging in neurofibromatosis type I with the question of a malignant transformation of the neurofibromas and for biopsy or surgery planning
• Written consent of the legal guardian and, if applicable, the child (depending on the individual stage of development) to participate in the study and to report so-called incidental findings after detailed explanation

Exclusion Criteria

• Presence of non-MRI-compatible implants or any kind of metal in and on the body (e.g. pacemakers, artificial heart valves, metal prostheses, implanted, magnetic metal parts, coils, etc.)
• Children and adolescents who report a hearing disorder or an increased sensitivity to loud noises
• Children and adolescents with reduced temperature sensation and/or increased sensitivity to warming of the body
• pregnancy
• Diabetes mellitus that cannot be controlled with medication

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The study is primarily used for quality assurance and optimization of PET/MRI examinations in pediatric oncology. For PET/fMRI hybrid imaging, the clinical benefit for children and adolescents with solid tumors is to be determined. The clinical benefit is defined here as a change in patient management (diagnostic and therapeutic) based on the PET/MRI examination.

Secondary Outcome Measures

Name	Time	Method
The data should be used to optimize the PET/MRI examination protocols with regard to possible time and dose reductions.