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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 trial about?

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

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

  • FAPI-PET/CT

    This medication is not a traditional drug but a diagnostic imaging technique used in the form of a PET/CT scan. It is currently being studied for its ability to detect active fibroblasts and inflammation in the penis, specifically in patients with acute phase Peyronie's Disease. The main therapeutic indication is to help identify areas of active disease, which can guide treatment decisions. At the molecular level, FAPI-PET/CT works by targeting fibroblast activation protein, which is often present in areas of tissue remodeling and inflammation. It falls under the pharmacological classification of diagnostic radiopharmaceuticals.

  • FDG-PET/CT

    Similar to FAPI-PET/CT, this is a diagnostic imaging method rather than a medication, administered as a PET/CT scan. It is used to detect inflammation and active disease processes in various conditions, including acute phase Peyronie's Disease. The technique involves using a glucose-based tracer that highlights areas of increased metabolic activity, which often correspond to inflammation or disease. FDG-PET/CT is classified as a diagnostic radiopharmaceutical and is widely used in medical imaging to assess metabolic activity in tissues.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518838-82-00Protocol codeHippocratesEstimated enrolment20 patientsSponsorUniversitair Medisch Centrum Groningen

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