A Phase 4 interventional study of 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) in Peyronie's Disease, sponsored by University Medical Center Groningen. Recruiting at 1 site in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University Medical Center Groningen · Phase 4, Interventional, and Diagnostic
The goal of this clinical trial is to learn if FAPI-PET/CT and/or FDG-PET/CT scan is able to detect active fibroblast tissue and inflammation in patients with acute or chronic phase PD.
The use of FAPI-PET/CT and FDG-PET/CT scan in acute or chronic phase Peyronie's disease for detection of active fibroblasts and inflammation in the penis - a pilot study
Rationale Peyronie's Disease (PD) causes curvature of the penis due to grow of fibroblasts, leading to an inflammatory reaction in the Tunica Albuginea. It's causing pain in the acute phase in 20-70% of men. New pharmaceutical therapies are being developed, but these are only suitable for the active phase of PD. It is difficult to differentiate between the active phase with inflammation and active fibrosis, and the chronic phase with end stage fibrosis. At this moment, this differentiation can only be done by taking the history of the patient and physical examination.
Having a diagnostic test that is able to distinguish between the active and chronic phase will be ground-breaking and will support the decision to prescribe the new pharmaceutical options in the future.
FAPI-PET/CT scan is able to show active fibroblasts in tumour tissue. Recent studies also showed that this imaging technique is able to detect active fibroblasts in benign diseases, like idiopathic retroperitoneal fibrosis.
FDG-PET/CT scan can visualise active fibroblasts and inflammation based on enhanced uptake of glucose inside the fibroblasts and other inflammatory cells
Objective To evaluate if FAPI-PET/CT and/or FDG-PET/CT scan is able to detect active fibroblast tissue and inflammation in patients with acute phase PD.
To evaluate if FAPI-PET/CT and/or FDG-PET/CT scan is able to show fibrotic tissue (chronic phase) in a different way to distinguish between acute phase PD and chronic phase PD.
Main trial endpoints Primary: Detection of active fibroblasts (uptake of FAPI) and/or inflammation (uptake of FDG) in the penis of PD patients with FAPI-PET/CT scan and FDG-PET/CT scan.
No detection of FAPI and/or FDG uptake in chronic fibrotic tissue.
Trial design Pilot study
Trial population Ten patients >18 years with PD diagnosis, new onset \< 6 months, painful erections, curvature and palpable nodule. Ten patients diagnosed with chronic PD will be included.
Interventions FAPI-PET/CT scan and FDG-PET/CT.
Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of patients represented by the trial subjects as well as the nature and extent of burden and risks Nature and extent of the burden and risks associated with participation, benefit and group relatedness: After diagnosis of PD a FAPI-PET/CT scan will be performed in UMCG and \< 2 weeks, before or after this, a FDG-PET/CT scan in St. Antonius Hospital. The scans will be performed as soon as possible.
After diagnosis of PD in chronic phase a FAPI-PET/CT scan will be performed in UMCG and a FDG-PET/CT scan in St. Antonius Hospital.
47 studies on the registry are indexed under Penile Induration; 10 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 39 interventional studies indexed under Penile Induration.
Browse Penile Induration studies →University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 176 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)
1 dosage for PET/scan of 200 MBq
In first ten PD patients detection of active fibroblasts (uptake of FAPI) and/or inflammation (uptake of FDG) in the penis with PET/CT scan. In second ten PD Patients no detection of chronic fibrotic tissue with FAPI and/or FDG uptake with PET/CT scan.
Time frame: From enrollment to after the second PET/CT scan. The PET/CT Scan will be performed within 2 weeks after enrollment in the active phase. At least 24 hours between the two PET/CT scans. No timelimit in the chronic phase for first PET/CT scan.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: 68Ga-FAPI
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