RecruitingRare disease

Using 68Ga-FAPI-46 imaging to detect fibrosis in patients with inflammatory diseases such as Crohn's disease, ulcerative colitis, systemic sclerosis, and lung fibrosis.

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on several conditions involving fibrosis, which is the development of excess scar tissue in the body. The diseases being studied include Idiopathic inflammatory myopathy, Crohn's disease, Ulcerative colitis, Fibrotic hypersensitivity pneumonitis, Idiopathic pulmonary fibrosis, Unclassifiable interstitial lung disease, and Systemic sclerosis. These conditions are often part of a group known as immune-mediated inflammatory diseases, where the body's immune system causes inflammation that can lead to organ damage.

The purpose of the study is to evaluate the use of 68Ga-FAPI-46 to detect scar tissue inside the body. This substance is a radiopharmaceutical, which is a specialized drug used for medical imaging. Participants will undergo a PET/CT scan, a method that combines two types of imaging to create detailed pictures of the body's internal structures. During the process, the substance is administered through an intravenous injection, meaning it is delivered directly into a vein.

Throughout the study, the imaging results will be compared with biological samples to see how well the scan identifies certain markers of scarring. Researchers will also look at how the substance moves through the body and how it can be used to better understand the progression of these diseases. This information may help in finding new ways to diagnose or treat scarring in the future.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
<b>imaging procedure</b>
An intravenous injection (a small tube inserted into a vein) of a solution for injection called 68Ga-FAPI-46 is administered.
The dose of this substance is 500 MBq (megabecquerels, a unit used to measure radioactivity).
A PET/CT scan is performed. this is a specialized imaging test that uses a radioactive tracer to create detailed pictures of the body to look for fibrosis (the formation of excess connective tissue or scarring in organs).
Step 2
<b>sample collection</b>
tissue samples are collected to analyze FAP (fibroblast activation protein, a marker related to tissue scarring) and other potential markers of fibrosis.
serum (the liquid part of the blood) is also collected to measure levels of these markers.

Who can join the trial?

10 criteria

You must be 18 years of age or older.
You must be able to undergo a PET/CT scan, which is a special imaging test that uses a small amount of radioactive material to show how organs and tissues are working, and a pulmonary function test, which measures how well your lungs work.
For people with Crohn's disease, you must have fibrostenotic disease, which means scarring that has caused a narrowing in the intestines, confirmed by an endoscopy (using a small camera to look inside the body) or an ultrasound.
For people with Ulcerative colitis, you must have the condition that does not respond to treatment and requires surgery, or a quiet version of the disease that requires regular endoscopy to monitor it.
For people with Systemic sclerosis, you must have active interstitial lung disease (scarring in the lung tissue), lung disease that has not progressed for two years, or advanced stage lung disease.
For people with Idiopathic inflammatory myopathy, you must have active myositis (inflammation of the muscles) and a clinical need to begin immunosuppressive agents, which are medicines used to lower the activity of the immune system.
For people with Fibrotic hypersensitivity pneumonitis, Unclassifiable interstitial lung disease, or Idiopathic pulmonary fibrosis, you must have HRCT data (a high-resolution type of CT scan) from the last 12 months that shows at least 20% of the lung parenchyma (the functional tissue of the lungs) is affected by scarring or fibrosis.
For the lung conditions mentioned above, your FVC (the total amount of air you can breathe out after taking a deep breath) must be at least 45% of the normal expected value.
For the lung conditions mentioned above, your FEV1/FVC ratio (a measurement of how much air you can blow out in one second compared to the total air you can blow out) must be 0.7 or higher.
For the lung conditions mentioned above, your DLco (a test that measures how well oxygen passes from the lungs into the blood) must be at least 40% of the normal expected value after being adjusted for your hemoglobin (the protein in red blood cells that carries oxygen).

Who cannot join the trial?

9 criteria

Being pregnant or currently breastfeeding.
Being unable to provide written consent, which is the formal signed agreement to participate in the study.
Having received any previous anti-fibrotic treatment, which are medicines used to slow down the scarring of tissue, unless the patient has end-stage ILD (a condition where interstitial lung disease, or lung scarring, has reached its final, most advanced stage).
Having IBD (Inflammatory Bowel Disease, a condition involving swelling in the digestive tract) along with colorectal carcinoma (cancer of the colon or rectum) or high-grade dysplasia (a condition where cells look abnormal under a microscope and may become cancer).
Having ILD (interstitial lung disease, which involves scarring of the lung tissue) combined with pulmonary fibrosis (scarring of the lungs) and emphysema (a condition where air sacs in the lungs are damaged).
Having uncontrolled severe asthma.
Having an active malignancy (a currently growing cancer), except for certain types like squamous cell carcinoma of the skin, low-risk breast cancer, or low-risk prostate cancer.
Showing signs of upper or lower respiratory tract symptoms (problems with the nose, throat, or lungs) during the 6 weeks before the study screening begins.
Having any other health conditions or circumstances that, in the opinion of the study doctor, would make it difficult to perform the PET/CT (a special type of medical imaging scan) or evaluate the progress of pulmonary fibrosis (lung scarring).

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Amsterdam UMC
Responsive
Amsterdam, The Netherlands

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Investigated drugs

68Ga-FAPI-46 is a specialized liquid injection used for medical imaging. It works by traveling through the bloodstream to help doctors see and locate areas of scarring, known as fibrosis, inside the body using a PET/CT scan.

(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-Cyano-4,4-Difluoropyrrolidin-1-Yl)-2-Oxoethylcarbamoyl)-Quinolin-6-Yl)(Methyl)Amino)-Propyl)Piperazin-1-Yl)-2-Oxoethyl)-68Ga-[1,4,7,10]-Tetraazacyclododecane-1,4,7-Triyl)Triacetate

What is already known about the treatment

68Ga-FAPI-46 - This medication is a radioactive liquid solution administered through an injection into a vein. Currently used as a diagnostic tool in medical research, it is designed to help doctors visualize areas of tissue scarring, known as fibrosis, in conditions like Crohn's disease, ulcerative colitis, and various lung diseases. It works by specifically targeting and binding to fibroblast activation protein, a molecule found on the surface of cells that are actively involved in creating scar tissue. It is classified as a diagnostic radiopharmaceutical used for advanced medical imaging.

Investigated diseases

Idiopathic inflammatory myopathy
This is a group of rare disorders characterized by inflammation of the muscles. The condition typically involves muscle weakness that may develop gradually or suddenly. It can also affect other tissues such as the skin and lungs. As it progresses, the inflammation can lead to muscle damage and scarring.
Crohn's disease
This is a chronic condition that causes inflammation in the digestive tract. It can affect any part of the gastrointestinal tract from the mouth to the anus. The inflammation often occurs in patches, leaving healthy areas in between. Over time, the inflammation can cause swelling and thickening of the intestinal walls.
Ulcerative colitis
This is an inflammatory bowel disease that primarily affects the large intestine and rectum. It causes long-lasting inflammation and sores called ulcers on the inner lining of these organs. The disease typically starts in the rectum and spreads upward through the colon. The inflammation can lead to continuous changes in the intestinal lining.
Fibrotic hypersensitivity pneumonitis
This is a lung condition caused by an immune system reaction to inhaled organic dusts or chemicals. The inflammation can lead to the development of permanent scarring, known as fibrosis, in the lung tissue. As the scarring increases, the lung tissue becomes stiff and less efficient. This process can occur in stages following repeated exposure or a single intense event.
Idiopathic pulmonary fibrosis
This is a condition where the lungs become thick, stiff, and scarred for unknown reasons. The scarring occurs within the lung tissue and develops gradually over time. As more tissue is replaced by scar tissue, it becomes increasingly difficult for the lungs to function properly. The progression involves a continuous buildup of this fibrous material.
Unclassifiable interstitial lung disease
This refers to a group of lung disorders characterized by inflammation or scarring that does not fit into specific known categories. These diseases affect the tissue and spaces around the air sacs in the lungs. The condition progresses through various patterns of lung injury and tissue remodeling. The exact nature of the progression varies depending on the underlying cause.