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.
Recruiting
Phase 2Phase 3Interventional Study
Fever of Unknown OriginIgG4 Related DiseaseAxial Spondylarthritis (axSpA)Inflammation of Unknown Origin
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Diagnostic
Participants needed
140 (estimated)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Other
Who this trial is looking for
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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
Trial Locations
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Eligibility Criteria
Inclusion Criteria FUO:
* 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.
Inclusion criteria IgG4-RD:
* High clinical suspicion of I…
Inclusion Criteria FUO:
* 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.
Inclusion criteria IgG4-RD:
* High clinical suspicion of IgG4-RD by an experienced clinician of Internal Medicine, based on anamnesis, physical examination, first-line investigations and blood tests.
* Patients with a new diagnosis of IgG4-RD on histopathology and need for further assessment of disease extent with PET/CT,
* Relapse of diagnosed IgG4-RD on histopathology according to an experienced clinician of Internal Medicine
Inclusion criteria AxSpA:
* High clinical suspicion of axial spondyloarthropahy according to an experienced rheumatology (based on inflammary back pain \> 3 months, insidious onset, morning stifness, improvement with exercise and worsening in rest, pain worse at night, age at onset \<45 years of age, imaging findings).
* Patient has persisting inflammatory back pain after 2 different types of NSAID's (tried for over 2-4 weeks), and is therefore eligible for biological DMARDS therapy.
Exclusion Criteria:
* 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).
* Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.
* Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.
* Participant has a known hypersensitivity to \[18F\]AlF-FAPI-74 or the used excipients.
* Active treatment has already commenced
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