Trials Sponsors Conditions Drugs Pricing

Conditions

Paediatric sarcoma Sarcoma

Keywords

pediatric sarcomaWB PET/MRIFAPIWB PET/CT

Outcome Measures

Primary Outcomes (1)

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.
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
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.

Study Arms (1)

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.

Drug: FAPI tracer

Interventions

FAPI tracerDrug

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

Also known as: IMP

Experimental scans

68GA-FAPI-46Type not reported

Eligibility Criteria

AgeUp to 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

\<18 years old.
Referred to the Recruiting Department for evaluation of any type of sarcoma.

Sponsors & Collaborators

Rigshospitalet
Type not reportedlead
Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Denmark
Type not reportedcollaborator

Study Sites (1)

Dept. of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 CPH

Copenhagen, 2100, Denmark

Marie Øbro Fosbøl, MD, PhD, Specialist physicianCONTACT0045 3545 3919 marie.oebro.fosboel@regionh.dk

MeSH Terms

Conditions

Sarcoma

Interventions

Inosine Monophosphate

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Inosine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotides

Central Study Contacts

Sabrina Honoré d'Este, MD, Ph.D. student

CONTACT

0045 4535 4736 sabrina.honore.deste.01@regionh.dk

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD, PhD, certified specialist in Clinical Physiology and Nuclear Medicine

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 6, 2026

Study Start

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

December 2028

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Experimental scans

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Experimental scans

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations