SarcomaPhase 2PsiFINCT07861217
Paediatric Sarcoma, Hybrid Imaging & FAPI - Raising the Diagnostic Standard for Paediatric Sarcoma Patients, Combining Novel Radiotracer FAPI and Whole-body PET/MRI
A Phase 2 study testing FAPI tracer in people with Sarcoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- FAPI tracer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2026to Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- <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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Dept. of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 CPH
Copenhagen, 2100
Marie Øbro Fosbøl, MD, PhD, Specialist physician, 0045 3545 3919, marie.oebro.fosboel@regionh.dk
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Sarcoma
- Being tested
- FAPI tracer
- Keywords
- pediatric sarcoma, WB PET/MRI, FAPI, WB PET/CT
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI tracerDrug
Also called IMP
The patient is administered 2.0 MBq/kg of [68Ga]FAPI-46 radioactive tracer.
| Study group | Role | What they receive |
|---|---|---|
| Experimental scans | Active comparator | Each patient is administered a radioactive dose of [68Ga]FAPI-46 and undergoes a whole-body PET/MRI followed by a whole-body PET/CT on the same dose administration. Receives: Drug: FAPI tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Clinical Physiology and Nuclear Medicine, Rigshospitalet, Denmark, Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Denmark, Department of Pathology, Rigshospitalet, Denmark, Department of Clinical Medicine, University of Copenhagen, Denmark
- Responsible party
- Principal investigator, Marie Øbro Fosbøl, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861217
- Sponsor's protocol ID
- PsiFI
- Other IDs
- 2025-001412, 2025-524874-41-00, 2025
- Acronym
- PsiFI
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared as the trial population are minors. Specific data can be supplied upon request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07861217
- Acronym / sponsor ID
- PsiFI / PsiFI
- Conditions
- Sarcoma
- Keywords
- pediatric sarcoma, WB PET/MRI, FAPI, WB PET/CT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Department of Clinical Physiology and Nuclear Medicine, Rigshospitalet, Denmark, Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Denmark, Department of Pathology, Rigshospitalet, Denmark, Department of Clinical Medicine, University of Copenhagen, Denmark
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental scans | Active comparator | Drug: FAPI tracerEach patient is administered a radioactive dose of [68Ga]FAPI-46 and undergoes a whole-body PET/MRI followed by a whole-body PET/CT on the same dose administration. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- <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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAPI tracerAlso: IMPThe patient is administered 2.0 MBq/kg of [68Ga]FAPI-46 radioactive tracer. | Drug | Experimental scans |
Primary outcome
Endpoint for the primary objective
Time frame: 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.
1 secondary outcome
Endpoint of the secondary objective
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared as the trial population are minors. Specific data can be supplied upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FAPI tracer in people with Sarcoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Honoré d'Este, MD, Ph.D. student (0045 4535 4736, sabrina.honore.deste.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endpoint for the primary objective (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.