The goal of this clinical trial is to evaluate \[68Ga\]FAPI-46 whole-body PET/MRI as a diagnostic tool to improve tumour lesion examination at primary staging, during treatment control and at relapse in paediatric sarcoma patients.
The main questions the trial aim to answer are:
* Is \[68Ga\]FAPI-46 whole-body PET/MRI better at detecting malignancy in paediatric sarcoma patients compared to current standard of care imaging modalities? * Is the overall diagnostic performance of \[68Ga\]FAPI-46 whole-body PET/MRI feasible to implement in clinical practice?
The intervention of \[68Ga\]FAPI-46 will be compared to current standard of care imaging modalities. All participants will receive their standard of care imaging protocol as rutinely scheduled, which includes:
* A localized MRI scan of the tumour region and * An \[18F\]FDG whole-body PET/CT scan
In addition to the standard of care imaging protocol, all patients will receive the following experimental scans:
* An \[18F\]FDG whole-body PET/MRI * A \[68Ga\]FAPI-46 whole-body PET/MRI * A \[68Ga\]FAPI-46 whole-body PET/CT
All patients and legal guardians will fill out questionnaires on their experiences. Patients may undergo the entire trial imaging procedures, including the standard of care imaging protocol and the experimental scans, a maximum of five times.
<18 years old.
Referred to the Recruiting Department for evaluation of any type of sarcoma.
The patient and/or parent(s) must be able to read and understand the Participant Information Sheet (PIS) in Danish and/or English and provide innformed consent by signing the Informed Consent Form (ICF).
Pregnancy or lactation.
Considered unable by the referring department to comply with the study imaging procedures without sedation.
Severe claustrophobia or any contraindication indentified through the MRI safety screening questionnaire.
History of an allergic reaction due to compounds with a chemical composition similar to that of [68Ga]FAPI-46.
Single group
FAPI tracer
DrugThe patient is administered 2.0 MBq/kg of \[68Ga\]FAPI-46 radioactive tracer.
Endpoint for the primary objective
The primary objective is to evaluate physicians' ability to accurately detect malignancy on \[68Ga\]FAPI-46 WB PET/MRI compared with standard-of-care imaging modalities. This will be assessed by calculating sensitivity, specificity, and positive and negative predictive values, using histopathology as the reference standard. If histopathology is unavailable, true positives may also be defined by consensus among the evaluating physicians, based on available imaging and the patient's electronic medical record during the 6-month follow up period.
Endpoint of the secondary objective
Tissue samples collected as part of routine clinical care, will be used for immunohistochemical (IHC ) analysis of FAP expression. The histological presence of FAP in the tissue samples will be correlated with the standardized uptake value (SUV) of the corresponding lesion identified on \[68Ga\]FAPI-46 PET/MRI. A standardardized questionnaire will be used to assess the experiences of the patient and/or parent(s). A final qualitative assessment of the technical feasibility of implementing this imaging modality in clinical practice will be conducted as part of the overall study evaluation. This assessment will consider any site-specific challenges associated with executing the experimental imaging protocol, the results of the image interpretation analyses, additional experiences gained during the study, and the time and costs associated with the protocol compared with current standard-of-care imaging modalities.
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Copenhagen University Hospital, Rigshospitalet
Lead sponsor
Department of Clinical Physiology and Nuclear Medicine, Rigshospitalet, Denmark
Collaborator
Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Denmark
Collaborator
Department of Pathology, Rigshospitalet, Denmark
Collaborator
Department of Clinical Medicine, University of Copenhagen, Denmark
Collaborator
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