Ongoing Clinical Trials for Connective Tissue Disorder
This article provides information about ongoing clinical research for connective tissue disorder. Currently, there is 1 clinical trial actively recruiting patients. This trial focuses on early detection of lung complications using advanced imaging techniques in patients with connective tissue diseases who are at risk of developing lung fibrosis.
Clinical trial locations
Study of [18F]FAPI-74 PET/CT Imaging in Patients with Connective Tissue Disease at Risk of Lung Fibrosis
This research study is being conducted in Italy and focuses on patients with connective tissue diseases who have a high risk of developing interstitial lung disease, a condition that causes scarring of the lung tissue. The trial uses an advanced imaging approach to better understand and predict how lung disease may progress in these patients.
Main goal of the trial: The primary purpose of this study is to compare detailed lung images between patients whose lung condition may worsen over time and those whose condition remains stable. Researchers want to see if special imaging can help identify early signs of lung tissue damage before it becomes more serious. The study uses a substance called [18F]FAPI-74, which is injected into a vein and helps create very detailed images of the lungs using PET/CT scanning technology. The research also examines tiny particles in the blood called extracellular vesicles that may provide additional information about lung health.
Who can participate – Inclusion criteria:
- Adults between 18 and 75 years old, both men and women
- Diagnosed with one of the following conditions: Systemic Sclerosis, Rheumatoid Arthritis, Sjögren’s Syndrome, Inflammatory Muscle Disease, or Undifferentiated Connective Tissue Disease
- Specific blood test results showing certain antibodies related to their condition
- Evidence on a recent high-resolution CT scan (within the past 6 weeks) showing that at least 10% of lung tissue has interstitial changes
- Either never taken immune-suppressing medications, or have been on a stable dose for at least 3 months
- If previously treated with rituximab, the last dose must have been more than 24 weeks (about 6 months) ago
- Ability to sign an informed consent form
Who cannot participate – Exclusion criteria:
- Anyone under 18 years old
- People with claustrophobia, as the imaging tests require lying in enclosed machines
- Pregnant or breastfeeding women
- Recent major surgery within the last 3 months
- Metal implants or devices that would interfere with imaging
- Inability to lie flat for at least 30 minutes during scanning
- Severe kidney disease
- Known allergies to contrast materials used in imaging
- Currently participating in other clinical trials
- Other medical conditions that are not well controlled
- Received experimental treatments within the past 30 days
What the study involves: Participants will undergo several steps over a 12-month period. First, a high-resolution CT scan confirms the presence of lung tissue changes. Then, participants receive an injection of the imaging substance [18F]FAPI-74 and undergo a special PET/CT scan to examine their lung tissue in detail. Throughout the 12-month monitoring period, regular check-ups track any changes in lung function. In some cases where the lung condition shows signs of worsening, doctors may perform a bronchoalveolar lavage, a procedure where fluid samples are collected from the lungs to study the lung environment more closely. At the end of 12 months, lung function is assessed again to determine if any progression has occurred, and this is compared with the initial scan results.
Investigational approach: This trial is an observational study that does not test any medications. Instead, it uses advanced imaging technology to observe and track disease progression. The focus is on diagnostic imaging rather than therapeutic intervention, helping researchers better understand how lung disease develops in patients with connective tissue disorders.
Summary
Currently, there is one active clinical trial available for patients with connective tissue disorder, specifically focusing on those at risk of developing lung fibrosis. This trial is taking place in Italy and represents an important research effort to improve early detection of lung complications in this patient population.
The study takes an innovative approach by using advanced imaging techniques rather than testing medications. It aims to identify patterns that can help predict which patients are likely to experience worsening lung disease over time. This information could eventually help doctors make earlier treatment decisions and monitor patients more effectively.
Patients interested in participating should note that this study requires a commitment to follow-up visits over 12 months and involves imaging procedures that require lying still in scanning machines. The research focuses specifically on patients with confirmed connective tissue diseases who already show some evidence of lung involvement on imaging tests.