Study on Sodium Fluoride (18F) PET-CT Scans for Detecting Bone Changes in Psoriasis Patients at Risk of Psoriatic Arthritis

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What is this study about?

This clinical trial is focused on studying Psoriasis, a skin condition that causes red, itchy, and scaly patches, and its potential progression to Psoriatic Arthritis, a type of arthritis that affects some people with psoriasis. The study will use a special imaging technique called [18F]Fluoride PET-CT to look for new bone formation in the body. This imaging method involves a solution called Sodium Fluoride (18F), which is injected into the body to help highlight areas of interest during the scan.

The purpose of the study is to see if this imaging technique can effectively detect changes in the bones of people with psoriasis who are at risk of developing psoriatic arthritis. Participants will undergo whole-body scans to identify any new bone growth. The study will track the number and location of any positive findings from the scans. Additionally, researchers will observe how these findings relate to the development of psoriatic arthritis over a two-year period.

Throughout the study, participants will receive the Sodium Fluoride (18F) injection and undergo the PET-CT scan. The study aims to provide valuable insights into the early detection of bone changes in psoriasis patients, potentially leading to better management and treatment of those at risk for psoriatic arthritis. A placebo may be used in some cases to compare results. The study is expected to continue until 2027.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of psoriasis and ensuring the patient is 18 years or older.

The presence of joint pain or inflammation in at least one location for no more than one year, not caused by trauma, is required.

Additional criteria include having nail psoriasis, a first-degree relative with psoriatic arthritis, or a body surface area affected by psoriasis of 3% or more.

2 preparation for imaging

Patients are prepared for imaging using a solution for injection containing sodium fluoride (18F). This is administered through an intravenous injection.

The solution is known as Sodium Fluoride (18F) Life Radiopharma 0.1 – 4 GBq/ml.

3 PET-CT scan

A PET-CT scan is performed to detect new bone formation in the body. This scan helps identify areas with increased fluoride uptake, which may indicate potential development of psoriatic arthritis.

The scan focuses on both axial (spine) and peripheral (limbs) regions.

4 data analysis

The primary endpoint is to determine the number and distribution of PET-positive lesions.

Secondary endpoints include analyzing the correlation between PET scan results and the development of psoriatic arthritis over a two-year follow-up period, as well as measuring the fluoride uptake in PET-positive lesions.

5 follow-up

Patients are monitored for up to two years to observe any development of psoriatic arthritis.

Regular follow-ups are conducted to assess the correlation between initial PET scan findings and any clinical manifestations of the disease.

Who Can Join the Study?

Must have a diagnosis of psoriasis, which is a skin condition that causes red, itchy, and scaly patches.
Must be 18 years old or older.
Must have experienced arthralgia (joint pain) or enthesiopathy (pain where tendons or ligaments attach to the bone) in at least one location for one year or less, and it should not be due to an injury.
Must have at least one of the following: Nail psoriasis (psoriasis affecting the nails), a first-degree relative with PsA (psoriatic arthritis), or a BSA (body surface area) affected by psoriasis of 3% or more.
Both males and females can participate.

Who Cannot Join the Study?

Patients who do not have psoriasis cannot participate. Psoriasis is a skin condition that causes red, itchy, and scaly patches.
Patients who are not at risk of developing psoriatic arthritis cannot participate. Psoriatic arthritis is a type of arthritis that affects some people with psoriasis, causing joint pain and swelling.
Patients who are not within the specified age range cannot participate. The study includes certain age groups, so if you are too young or too old, you may not be eligible.
Both male and female patients can participate, so gender is not a reason for exclusion.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people who cannot make decisions for themselves.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Asieqvxla Udj	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.05.2024

Trial locations

Investigated drugs:

Sodium Fluoride (18F)

[18F]Fluoride: This is a special type of imaging agent used in PET-CT scans. In this study, it helps to create detailed images of the bones. The purpose is to see if there are any new bone formations in patients with psoriasis who might develop psoriatic arthritis. This imaging agent helps doctors to detect changes in the bones that might not be visible with other types of scans.

Investigated diseases:

Psoriasis

Psoriasis – Psoriasis is a chronic skin condition characterized by the rapid growth of skin cells, leading to thick, red, scaly patches on the skin. These patches can appear anywhere on the body but are most commonly found on the elbows, knees, scalp, and lower back. The condition is believed to be related to an immune system problem with T cells and other white blood cells, called neutrophils, in the body. Psoriasis can vary in severity, with some people experiencing only minor patches and others having more widespread and severe symptoms. The condition often goes through cycles, flaring for a few weeks or months, then subsiding or going into remission. Environmental factors, such as stress, infections, and cold weather, can trigger or worsen the symptoms.

Trial ID:

2024-514759-13-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Sodium Fluoride (18F) PET-CT Scans for Detecting Bone Changes in Psoriasis Patients at Risk of Psoriatic Arthritis

What is this study about?

Who Can Join the Study?

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