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Study on the Use of FAPI-PET/CT and FDG-PET/CT Scans for Detecting Active Fibroblasts and Inflammation in Patients with Acute Phase Peyronie’s Disease

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What is this study about?

This clinical trial is focused on studying Peyronie’s Disease, a condition that affects the penis and can cause painful erections and the development of a hard lump or nodule. The study aims to explore the use of two types of scans, FAPI-PET/CT and FDG-PET/CT, to detect active fibroblast tissue and inflammation in patients who are in the early stages of this disease.

The treatment being investigated involves the use of a special solution for injection called [68Ga]FAPI-46. This solution is designed to help highlight areas of active fibroblast activity and inflammation during the scans. The purpose of the study is to determine if these scans can effectively identify these active areas in the penis, which could help in understanding and diagnosing the condition better.

Participants in the study will undergo these scans to see if the FAPI-PET/CT and FDG-PET/CT can detect the active fibroblasts or inflammation. The study will take place over a period, and the results will help researchers understand the potential benefits of using these scans in diagnosing Peyronie’s Disease during its acute phase.

1 joining the study

Upon joining the study, you will be asked to provide written consent. This means you agree to participate after understanding the study’s purpose and procedures.

You must meet certain criteria, such as experiencing painful erections for less than six months, having a palpable nodule, being over 18 years old, and understanding the Dutch language.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This may involve a physical examination and a review of your medical history.

3 imaging procedure

You will undergo two types of scans: FAPI-PET/CT and FDG-PET/CT. These scans are used to detect active fibroblast tissue and inflammation in the penis.

For the FAPI-PET/CT scan, you will receive an injection of a solution called [68Ga]FAPI-46. This is administered through an intravenous injection, which means it is injected directly into a vein.

4 follow-up

After the imaging procedures, there may be follow-up appointments to discuss the results and any findings related to the detection of active fibroblasts or inflammation.

The study aims to evaluate the effectiveness of these scans in diagnosing acute phase Peyronie’s Disease.

Who Can Join the Study?

  • Must have painful erections that started less than 6 months ago.
  • Must have a palpable nodule (a lump that can be felt).
  • Must be a man older than 18 years of age.
  • Must be mentally competent and understand the benefits and potential burdens of the study.
  • Must be able to sign a written informed consent form.
  • Must be able to read and understand the Dutch language.

Who Cannot Join the Study?

  • Patients who do not have Peyronie’s Disease cannot participate.
  • Only male patients can participate; female patients are excluded.
  • Patients who are not in the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
  • Patients who belong to a vulnerable population are excluded. This usually means groups that need special protection, like children or people with certain disabilities, but specifics are not provided here.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Uftkcjqxcbud Mwnbtry Ckqtzmu Guecogrfm Groningen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.12.2024

Trial locations

Investigated drugs:

FAPI-PET/CT is a type of imaging scan used in this clinical trial. It helps doctors see if there are active fibroblasts, which are cells involved in the formation of fibrous tissue, in the penis of patients with Peyronie’s Disease. This scan can also show areas of inflammation, which is important for understanding the condition better.

FDG-PET/CT is another imaging scan used in the trial. It works by detecting areas of inflammation in the body. In this study, it is used to find inflammation in the penis of patients with Peyronie’s Disease. This helps doctors understand the extent of the disease and how active it is.

Investigated diseases:

Peyronie’s Disease – Peyronie’s Disease is a condition characterized by the development of fibrous scar tissue inside the penis, which can cause curved, painful erections. The disease often begins with inflammation, leading to the formation of hard plaques under the skin of the penis. Over time, these plaques can cause the penis to bend or become indented during erections. The progression of the disease can vary, with some men experiencing a stabilization of symptoms, while others may notice worsening curvature or pain. The acute phase of the disease is marked by active inflammation and the formation of new scar tissue. As the disease progresses, the inflammation may subside, leaving behind permanent changes in the shape of the penis.

Trial ID:
2024-518838-82-00
Protocol code:
Hippocrates
Trial Phase:
Therapeutic confirmatory (Phase III)

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