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Study on Gallium (68Ga) Chloride for Early Healing of Perianal Crohn's Disease Fistulas in Patients

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What is this trial about?

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

This clinical trial is focused on studying the healing process of a specific condition known as perianal Crohn's fistula, which is a complication of Crohn's disease. Crohn's disease is a long-term condition that causes inflammation of the digestive tract, and a fistula is an abnormal connection that can form between the intestine and the skin near the anus. The study will use a special imaging technique called FAPi-PET to observe the healing of these fistulas. The imaging involves a substance called Gallium (68Ga) Chloride, which is a type of radiopharmaceutical solution used to help visualize certain patterns in the body.

The purpose of the study is to see how well the 68Ga-FAPi-46 PET-CT scan can show and measure the activity of fibroblasts, which are cells involved in the healing process, during the early stages of healing in perianal Crohn's fistulas. Participants in the study will undergo imaging at the start and at different times during the study to track changes. The study will help researchers understand how the healing process can be monitored using this imaging technique.

Throughout the study, the researchers will collect visual and quantitative data from the imaging to assess how the fistulas are healing over time. This information will be compared with other clinical assessments to provide a comprehensive view of the healing process. The study aims to improve understanding of how to monitor and potentially enhance the treatment of perianal Crohn's fistulas using advanced imaging methods.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on the criteria for participation, including a confirmed diagnosis of Crohn's disease with specific characteristics of the perianal fistula.
Informed consent is obtained, ensuring understanding of the study's purpose and procedures.
Step 2
Baseline imaging
A baseline imaging procedure is conducted using a special scan called 68Ga-FAPi-46 PET-CT. This scan helps visualize and measure the activity in and around the perianal fistula.
The scan involves the administration of a solution called gallium (68ga) chloride through an infusion. This solution helps in capturing detailed images of the affected area.
Step 3
Follow-up imaging
Follow-up imaging is scheduled at specific intervals, either at week 2, week 6, or both, to monitor changes in the fistula's condition.
The same 68Ga-FAPi-46 PET-CT scan is repeated to compare with the baseline images and assess the healing process.
Step 4
Mid-treatment assessment
At week 9, a mid-treatment assessment is conducted. This includes clinical evaluations and possibly additional imaging to correlate with the scan results.
The goal is to understand the progress of healing and make any necessary adjustments to the treatment plan.
Step 5
End-of-treatment assessment
At week 26, the end-of-treatment assessment takes place. This involves a final set of evaluations and imaging to determine the overall effectiveness of the treatment.
The results from this assessment help in understanding the long-term impact of the treatment on the perianal fistula.

Who can join the trial?

4 criteria

Have a confirmed diagnosis of Crohn's Disease (CD) with inflammation in the digestive tract, which has been documented before or is currently present. This is usually confirmed through procedures like endoscopy (a camera used to look inside the body) and histopathology (examining tissue under a microscope).
Have a complex perianal fistula. This means the fistula (an abnormal connection between two body parts) involves the upper part of the muscle around the anus, has multiple openings, causes pain or swelling that might suggest an infection, or is linked with other complications like a connection between the rectum and vagina, a narrowing of the anal canal, or open sores in the rectum. The fistula should be actively draining fluid, even if it had closed before and reopened.
Be aged 16 or older.
Have signed a form agreeing to participate in the study, known as informed consent.

Who cannot join the trial?

10 criteria

Patients with any other **serious medical conditions** that could interfere with the study.
Patients who are **pregnant** or **breastfeeding**.
Patients who have had a **recent surgery** or are planning to have surgery during the study period.
Patients who are currently participating in another **clinical trial**.
Patients with a history of **allergic reactions** to the substances used in the study.
Patients who are unable to **understand** or **comply** with the study procedures.
Patients with **mental health conditions** that could affect their ability to participate.
Patients who have **substance abuse issues**, including alcohol or drugs.
Patients with **unstable or uncontrolled** medical conditions.
Patients who have had a **recent infection** or are currently experiencing an infection.

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Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

68Ga-FAPi-46 is a special type of imaging agent used in this clinical trial. It helps doctors see how well a certain type of tissue, called fibroblasts, is healing in people with perianal Crohn's disease. This agent is used in a PET-CT scan, which is a type of imaging test that combines two different scanning techniques to give a detailed picture of what's happening inside the body. The goal is to see if this imaging agent can show changes in the tissue as it starts to heal, which can help doctors understand the healing process better.

Gallium (68Ga) Chloride

What is already known about the treatment

68Ga-FAPi-46 – This medication is administered through a PET-CT scan, a type of imaging test that helps visualize and measure the activity of fibroblasts, which are cells involved in tissue repair. Currently, 68Ga-FAPi-46 is being studied in clinical trials to assess its effectiveness in detecting early healing of perianal Crohn's fistulas, a complication of Crohn's disease. The main therapeutic indication is to provide detailed images that can help doctors understand how well a fistula is healing. At the molecular level, 68Ga-FAPi-46 binds to fibroblast activation protein, which is often present in areas of tissue remodeling and inflammation. It is classified as a radiopharmaceutical used for diagnostic imaging.

Investigated diseases

Perianal Crohn's Fistula – This condition is a complication of Crohn's disease, characterized by the formation of abnormal connections between the anal canal and the skin near the anus. It occurs due to chronic inflammation, leading to the development of tunnels or fistulas. These fistulas can cause discomfort, pain, and drainage of pus or stool. The progression involves persistent inflammation and infection, which can lead to further complications if not managed. Over time, the fistulas may become more complex and difficult to manage. The condition requires careful monitoring to assess changes in the fistula's structure and activity.