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Early recognition of progressive lung fibrosis in systemic rheumatic diseases: a characterization of the pulmonary environment through extracellular vesicles, advanced and functional imaging
EU CTIS ID: 2024-516304-42-00
What this study is testing
To compare baseline FAPI PET/CT measures in CTD-ILD patients who will and will not experience lung functional progression at 12-month follow-up.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female and male aged between 18 and 75 years
- Signature of informed consent
- A clinical diagnosis of SSc, RA, SS, IIM, or UCTD that must adhere to internationally accepted classification criteria
- A high risk of ILD based on autoantibody profile, specifically: anti-Scl70+ or anti-RNAPIII+ for SSc, anti-CCP+ and/or RF+ for RA, anti-RoSSA+ and anti-LaSSB+ for primary SS, anti-synthetase+ for IIM. For UCTD patients, the enrollment criteria will be adapted to match those of Interstitial Pneumonia with Autoimmune Features (IPAF), with patients exhibiting one clinical feature of CTD and one serological domain criterion (e.g., ANA positive with nucleolar pattern, RF and anti-CCP positivity, anti-RoSSA and anti-LaSSB positivity, anti-Scl70 positivity) while not meeting the classification criteria for any other CTD
- Evidence of ILD based on an HRCT documenting the presence of interstitial changes involving at least 10% of the parenchyma within the previous 6 weeks
- Either naive to immunosuppressants or having been on a stable immunosuppressive regimen for the 3 months preceding FAPI PET/CT. Treatment with rituximab must be not administered in the previous 24 weeks
You likely can't join if
- Current treatment with corticosteroids > 10 mg of prednisone
- Women of childbearing potential tested positive at the urine pregnancy test performed just before FAPI PET/CT procedure
- Pregnancy, breastfeeding, or intention to undergo pregnancy within 6 months from the PET/CT scan
- Men who have a partner of childbearing age who intends or is likely to become pregnant in the 6 months following PET/CT
- Claustrophobia and/or inability to tolerate PET acquisition that would have an impact on the collection of a good quality scan
- Poor peripheral arterial and/or venous access that would interfere with radiopharmaceutical administration and/or blood sampling
See the full eligibility criteria
Who can join
- Female and male aged between 18 and 75 years
- Signature of informed consent
- A clinical diagnosis of SSc, RA, SS, IIM, or UCTD that must adhere to internationally accepted classification criteria
- A high risk of ILD based on autoantibody profile, specifically: anti-Scl70+ or anti-RNAPIII+ for SSc, anti-CCP+ and/or RF+ for RA, anti-RoSSA+ and anti-LaSSB+ for primary SS, anti-synthetase+ for IIM. For UCTD patients, the enrollment criteria will be adapted to match those of Interstitial Pneumonia with Autoimmune Features (IPAF), with patients exhibiting one clinical feature of CTD and one serological domain criterion (e.g., ANA positive with nucleolar pattern, RF and anti-CCP positivity, anti-RoSSA and anti-LaSSB positivity, anti-Scl70 positivity) while not meeting the classification criteria for any other CTD
- Evidence of ILD based on an HRCT documenting the presence of interstitial changes involving at least 10% of the parenchyma within the previous 6 weeks
- Either naive to immunosuppressants or having been on a stable immunosuppressive regimen for the 3 months preceding FAPI PET/CT. Treatment with rituximab must be not administered in the previous 24 weeks
- Specifically, patients that are candidates to BALF collection must have functional or radiological evidence of ILD deterioration to justify microbiological and cytological characterization of the lung environment before treatment upgrade
What rules you out
- Current treatment with corticosteroids > 10 mg of prednisone
- Women of childbearing potential tested positive at the urine pregnancy test performed just before FAPI PET/CT procedure
- Pregnancy, breastfeeding, or intention to undergo pregnancy within 6 months from the PET/CT scan
- Men who have a partner of childbearing age who intends or is likely to become pregnant in the 6 months following PET/CT
- Claustrophobia and/or inability to tolerate PET acquisition that would have an impact on the collection of a good quality scan
- Poor peripheral arterial and/or venous access that would interfere with radiopharmaceutical administration and/or blood sampling
- Specifically, the patient’s candidate for BALF collection must not have contraindications to the procedure, namely severe refractory hypoxemia and/or O2 therapy, uncontrolled active bronchospasm, history of unstable angina, history of myocardial infarction, history of unstable arrhythmias, platelet count <20,000/mm3 in the preceding 4 weeks, international normalized ratio or activated partial thromboplastin time ratio >1.5 evaluated in the preceding 4 weeks
- Clinical evidence of infection or positive microbiological tests on BALF analysis if performed
- known allergy or hypersensitivity to any component of the FAPI tracer
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.