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The Investigators Will Evaluate the Diagnostic Performance of [18F]-AlF-FAPI-74 PET/CT in Inflammatory Disorders and Compare it With the Current Gold Standard for Inflammation, FDG PET/CT, in Three Patient Cohort: Patients Presenting With Fever of Unknown Origin, IgG4-RD and AxSpA.

ConditionsFever of Unknown OriginIgG4 Related DiseaseAxial Spondylarthritis (axSpA)Inflammation of Unknown Origin
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

The aim of the study to evaluate the performance of new \[18F\]-AlF-FAPI-74 PET/CT in three inflammatory disorders (fever of unknown origin, IgG4-related disease and axial spondyloarthritis) and compare with the current stand-of-care \[18F\]-FDG PET/CT

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

An illness of more than 3 weeks' duration,

Temperature exceeding 38.3°C on > 3 occasions, or elevated inflammatory markers on > 3 occasions

Diagnosis uncertain despite appropriate first-line investigations.

High clinical suspicion of IgG4-RD by an experienced clinician of Internal Medicine, based on anamnesis, physical examination, first-line investigations and blood tests.

Disqualifiers

Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.

Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.

Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.

Female who is pregnant (urinary hCG test will be performed in every WOCBP), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).

Trial design

Design model

Single group

Treatments tested in this trial

  • [18F]AlF-FAPI-74 PET/CT

    Diagnostic test

    A \[18F\]AlF-FAPI-74 PET/CT will be performed at the same site of the screening visit (UZ Leuven). The patient will get an IV line, through which the \[18F\]AlF-FAPI-74 will be injected in one bolus (3,5 MBq/kg). After 60 minutes, the acquisition on the PET/CT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. If the patient receives therapy (for IgG4-RD and AxSpA), a second \[18F\]AlF-FAPI-74 PET/CT will be performed three months later.

Treatment groups

140 Participants
are divided into 3 treatment groups
Group A: FUO/IUOExperimental treatment 1 intervention
Group B: IgG4-related diseaseExperimental treatment 1 intervention
Group C: Axial SpondyloarthritisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

FUO/IUO: Demonstrate that the diagnostic performance of [18F]AlF-FAPI-74 PET/CT is equivalent or superior to the current gold standard, [18F] FDG PET/CT, in contributing to the final diagnosis (non-inferiority study with non-inferiority limit (10%)

Time frame
6 months after completion of both PET/CT scans
2

IgG4-RD: Demonstrate that the diagnostic performance of [18F]AlF-FAPI-74 PET/CT is superior to [18F]FDG PET/CT, in patients with suspicion of IgG4-RD and assessment of disease extent in patients with confirmed or relapsed IgG4-RD.

Time frame
After completion of both PET/CT scans before initiation of treatment and after completion of both PET/CT scans 3 months completion of treatment.
3

Axial Spondyloarthritis: evaluate the diagnostic accuracy of [18F]AlF-FAPI-74 PET/CT in differentiating inflammatory back pain in patients with axSpA from patients with mechanical back pain, and evaluate the ability to assess treatment response

Time frame
After completion of first PET/CT scan and after completion of PET/CT scan performed 3 months after treatment

Secondary outcomes

1

FUO/IUO: Determine the distribution of the four major causal group in FUO/IUO (infectious, inflammatory, malignant, and miscellaneous) of both tracers and evaluate for which causal groups [18F]AlF-FAPI-74 PET/CT is superior to [18F]FDG PET/CT.

Time frame
6 months after completion of all PET/CT scans
2

FUO/IUO: Evaluate for which entities [18F]AlF-FAPI-74 has the potential to outperform [18F]FDG PET/CT in lager patient cohorts.

Time frame
6 months after completion of all PET/CT scans
3

FUO/IUO: Determine the ratio of true positives, true negatives, false positives, false negative, positive predictive value, and negative predictive value.

Time frame
6 months after completion of all PET/CT scans
4

IgG4-RD: Semi-quantitative uptake measurements (maximal standardized uptake value (SUVmax), average SUV (SUVmean), peak SUV (SUVpeak) of lesions on [18F]AlF-FAPI-74 PET/CT and [18F]FDG PET/CT.

Time frame
After completion of both PET/CT scans before initiation of treatment and after completion of both PET/CT scans 3 months completion of treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov
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