Peyronie's DiseasePhase 4HippocratesNCT07903987
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
A Phase 4 study testing 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) in people with Peyronie's Disease, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronie's Disease
- What is being tested?
- 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Dec 2024to 15 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mentally competent and understanding of benefits and potential burden of the study
- be able to sign written informed consent
- read and understand the Dutch language active phase:
- painful erections,
- with onset for < 6 months
- palpable nodule
Show all 10Show fewer
- men >18 years of age chronic phase:
- Stable curvature of at least 6 months
- No painful erections for at least 6 months
- Palpable nodule
Who cannot join
- - Known other malignant disease
- For acute phase: Previous treatment for PD
- for chronic phase: Previous surgical treatment or treatment by injections for PD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
St Antoniusziekenhuis
Nieuwegein, Utrecht, 3435 CM
Jeannette P Geelhoed, MSc, +3119931803, j.p.geelhoed@umcg.nl
About this study
Official title: The Use of FAPI-PET/CT and FDG-PET/CT Scan in Acute and Chronic Phase Peyronie's Disease for Detection of Active Fibroblasts and Inflammation in the Penis - a Pilot Study
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.
- Does FAPI PET/CT scan or FDG PET/CT scan show any uptake of inflammatory tissue in patients with Peyronie's disease
- Participants will undergo a FAPI PET/CT scan and FDG PET/CT scan after diagnosis of Peyronie's disease.
Read the detailed description
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.
- Conditions
- Peyronie's Disease
- Being tested
- 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)
- Keywords
- Peyronie, Penile curvature, painful erections, erectile dysfunction
- Medical subject headings
- Penile Induration, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)Drug
1 dosage for PET/scan of 200 MBq
| Study group | Role | What they receive |
|---|---|---|
| Pilot study, only 1 arm | Experimental | Not described Receives: Drug: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start13 Dec 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie's DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Hospital
- Responsible party
- Sponsor
- Investigators
- Igle Jan de Jong, professor, Study director, University Medical Cener Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903987
- Sponsor's protocol ID
- METc 2022/299
- Other IDs
- 2024-518838-82-00, 2022-002770-82
- Acronym
- Hippocrates
- Status last verified
- Nov 2026
- First submitted
- 12 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of FAPI-PET/CT and FDG-PET/CT Scan in Acute and Chronic Phase Peyronie's Disease for Detection of Active Fibroblasts and Inflammation in the Penis - a Pilot Study
- ClinicalTrials.gov ID
- NCT07903987
- Acronym / sponsor ID
- Hippocrates / METc 2022/299
- Conditions
- Peyronie's Disease
- Keywords
- Peyronie, Penile curvature, painful erections, erectile dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- St. Antonius Hospital
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Does FAPI PET/CT scan or FDG PET/CT scan show any uptake of inflammatory tissue in patients with Peyronie's disease
- Participants will undergo a FAPI PET/CT scan and FDG PET/CT scan after diagnosis of Peyronie's disease.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot study, only 1 arm | Experimental | Drug: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- mentally competent and understanding of benefits and potential burden of the study
- be able to sign written informed consent
- read and understand the Dutch language active phase:
- painful erections,
- with onset for < 6 months
Key exclusion criteria (3 listed)
- - Known other malignant disease
- For acute phase: Previous treatment for PD
- for chronic phase: Previous surgical treatment or treatment by injections for PD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)1 dosage for PET/scan of 200 MBq | Drug | Pilot study, only 1 arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Igle Jan de Jong, professor study director
University Medical Cener Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) in people with Peyronie's Disease, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeannette P Geelhoed, MSc (+3119931803, j.p.geelhoed@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.