NCT07861217Not yet recruitingPhase 2
Paediatric Sarcoma, Hybrid Imaging & FAPI - Raising the Diagnostic Standard for Paediatric Sarcoma Patients, Combining Novel Radiotracer FAPI and Whole-body PET/MRI
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
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 25 Sept 2026
- Start date
- Dec 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT07861217
- EU CT number
- 2025-524874-41-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From Dec 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of an allergic reaction due to compounds with a chemical composition similar to that of \[68Ga\]FAPI-46.
Other
- 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.
Who the study is looking for
- \<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).
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.