Testing a new PET/MRI scan tracer for children and teens with sarcoma
Tests FAPI PET/MRI scans to find tumours in children with sarcoma.
Plain-language title generated from the registry record
Registry title: Paediatric Sarcoma, Hybrid Imaging & FAPI - Raising the Diagnostic Standard for Paediatric Sarcoma Patients, Combining Novel Radiotracer FAPI and Whole-body PET/MRI
Key facts
- Where
- Copenhagen Oe, DenmarkSee the site
- Phase
- Phase 2
Where in Denmark
- RigshospitaletCopenhagen Oe, DenmarkNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Copenhagen University Hospital, Rigshospitalet
- Trial code
- NCT07861217EU 2025-524874-41-00
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
Paediatric Sarcoma, Hybrid Imaging & FAPI - An Investigator-initiated, Non-inferiority, Single-group, Phase II Clinical Trial, Evaluating FAPI WB PET/MRI at Primary Staging, Treatment Control and Relapse in Paediatric Sarcoma - The PsiFI Trial
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.
Inclusion: <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).
Exclusion: History of an allergic reaction due to compounds with a chemical composition similar to that of [68Ga]FAPI-46; 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.