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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FUO/IUO | Experimental |
| |
| IgG4-related disease | Experimental |
| |
| Axial Spondyloarthritis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%) | 6 months after completion of both PET/CT scans | |
| 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. | After completion of both PET/CT scans before initiation of treatment and after completion of both PET/CT scans 3 months completion of treatment. | |
| 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 | After completion of first PET/CT scan and after completion of PET/CT scan performed 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after completion of all PET/CT scans | |
| FUO/IUO: Evaluate for which entities [18F]AlF-FAPI-74 has the potential to outperform [18F]FDG PET/CT in lager patient cohorts. |
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Inclusion Criteria FUO:
Inclusion criteria IgG4-RD:
Inclusion criteria AxSpA:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lennert Boeckxstaens, MD | Contact | +0032 16 34 37 15 | lennert.boeckxstaens@uzleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leuven | Recruiting | Leuven | 3000 | Belgium |
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Prospective, non-randomized, single center, multi-cohort, interventional phase II/III trial.
The three cohorts are: Fever or inflammation of unknown origin (FUO/IUO), IgG4-related disease (IgG4-RD) and Axial Spondyloarthritis (AxSpA).
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|
| 6 months after completion of all PET/CT scans |
| FUO/IUO: Determine the ratio of true positives, true negatives, false positives, false negative, positive predictive value, and negative predictive value. | 6 months after completion of all PET/CT scans |
| 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. | After completion of both PET/CT scans before initiation of treatment and after completion of both PET/CT scans 3 months completion of treatment. |
| IgG4-RD: Evaluate the organ detection ratio for every organ, defined as the percentage of patients with pathological uptake in that specific organ by each tracer for the total of number of patients with pathological uptake in that organ | After completion of both PET/CT scans before initiation of treatment and after completion of both PET/CT scans 3 months completion of treatment. |
| IgG4-RD: 4) Evaluate the total number of affected organs per patient for each tracer and calculate the difference for both tracers. Determine the total difference of affected organs between both tracers for all patients. | After completion of both PET/CT scans before initiation of treatment and after completion of both PET/CT scans 3 months completion of treatment. |
| IgG4-RD: Evaluate the treatment response of FAPI and FDG lesions by quantifying the change in SUVmax between baseline and post-therapy PET/CT scans. | After completion of both PET/CT scans before initiation of treatment and after completion of both PET/CT scans 3 months completion of treatment. |
| AxSpA: Semi-quantitative uptake measurements (maximal standardized uptake value (SUVmax), target-to-background (TBR)) of lesions in the spine and the sacro-iliac joints will be computed on [18F]AlF-FAPI-74 PET/CT in all patients | After completion of first PET/CT scan and after completion of PET/CT scan performed 3 months after treatment |
| AxSpA: Determine if there is a significant statistical difference (p<0.05) in semi-quantitative uptake measurements (SUVmax, TBR) between the two cohorts, and determine the optimal cut-off value. | After completion of first PET/CT scan and after completion of PET/CT scan performed 3 months after treatment |
| AxSPa: Assess treatment response by evaluating changes in semi-quantitative measurements (SUVmax, TBR) in patients with axSpA following 3 month treatment with bDMARDs. | After completion of first PET/CT scan and after completion of PET/CT scan performed 3 months after treatment |
| ID | Term |
|---|---|
| D005335 | Fever of Unknown Origin |
| D000077733 | Immunoglobulin G4-Related Disease |
| ID | Term |
|---|---|
| D005334 | Fever |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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