Overview
Sponsor-declared trial summary
Peyronie's Disease
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 Peyronie's Disease.
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 13 Dec 2024 → ongoing
- Decision date (initial)
- 2024-12-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- University Medical Centre Groningen, Urology Department
External identifiers
- EU CT number
- 2024-518838-82-00
- EudraCT number
- 2022-002770-82
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
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 Peyronie's Disease.
Conditions and MedDRA coding
Peyronie's Disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- -painful erections, -with onset for < 6 months, -palpable nodule, -men >18 years of age, -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
Exclusion criteria 1
- -Known other malignant disease, -Previous treatment for Peyronie's Disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Detection of active fibroblasts or inflammation in the penis of new onset PD patients with FAPI-PET/CT scan and/or FDG-PET/CT scan.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11595253 · Product
- Active substance
- (S-222-10-2-4-3-4-2-2-CYANO-44-DIFLUOROPYRROLIDIN-1-YL-2-OXOETHYLCARBAMOYL-QUINOLIN-6-YLMETHYLAMINO-PROPYLPIPERAZIN-1-YL-2-OXOETHYL-68GA-14710-TETRAAZACYCLODODECANE-147-TRIYLTRIACETATE
- Substance synonyms
- 68Ga-FAPI-46
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 200 MBq megabecquerel(s)
- Max total dose
- 40 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- UNIVERSITY MEDICAL CENTER GRONINGEN
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- prof. I.J. de Jong
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- prof. I.J. de Jong
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 20 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-12-13 | 2024-12-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_EU-CT 2022-002770-82 | 6 |
| Recruitment arrangements (for publication) | Blanc document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF-NL Patient Information File | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC FDG | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-16 | Netherlands | Acceptable 2024-12-05
|
2024-12-05 |