Paediatric Sarcoma, Hybrid Imaging & FAPI - Raising the Diagnostic Standard for Paediatric Sarcoma Patients, Combining Novel Radiotracer FAPI and Whole-body PET/MRI

Condition(s) studied

Investigational drug(s) / intervention(s)

FAPI tracer: The patient is administered 2.0 MBq/kg of \[68Ga\]FAPI-46 radioactive tracer.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Endpoint for the primary objective — From recruitment, at the time of each participant's initial evaluation, until 6 months after completion of participant recruitment. The trial duration, from the start of recruitment to end of participation, is expected to last 2.5 years.
  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.

Trial sites (1)

More Copenhagen University Hospital, Rigshospitalet trials in Denmark

Other trials for the same condition