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Compares treatment options for Fever of Unknown Origin
Official title 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.
ClinicalTrials.gov ID: NCT07535554
What this study is testing
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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. IgG4-RD:
- High clinical suspicion of IgG4-RD by an experienced clinician of Internal Medicine, based on anamnesis, physical examination, first-line...
You likely can't join if
- Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific...
- 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...
- Participation in an treatment Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by...
- Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.
See the full eligibility 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. 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 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...
- 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.
- 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...
- Participation in an treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.