Clinical trial • Phase IV • Other
(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Peyronie's disease
Phase IV trial of (S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZI…
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Peyronie's disease
- Trial Stage
- Phase IV
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 16-11-2024
- First CTIS Authorization Date
- 05-12-2024
Trial design
Phase IV trial across 2 sites in Netherlands.
- Target Sample Size
- 20
Eligibility
Recruits 20 No vulnerable populations selected. Participants must be mentally competent, able to sign written informed consent and read and understand the Dutch language. Only men >18 years are eligible; no assent process is indicated..
- Vulnerable Population
- No vulnerable populations selected. Participants must be mentally competent, able to sign written informed consent and read and understand the Dutch language. Only men >18 years are eligible; no assent process is indicated.
Inclusion criteria
- {"criterion_text":"-painful erections\n-with onset for < 6 months\n-palpable nodule\n-men >18 years of age\n-mentally competent and understanding of benefits and potential burden of the study\n-be able to sign written informed consent\n-read and understand the Dutch language"}
Exclusion criteria
- {"criterion_text":"-Known other malignant disease\n-Previous treatment for Peyronie's Disease"}
Endpoints
Primary endpoints
- {"endpoint_text":"-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.","definition_or_measurement_approach":"Detection assessed by FAPI-PET/CT and/or FDG-PET/CT imaging to identify active fibroblasts or inflammation in the penis of new-onset Peyronie's disease patients."}
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 7
- Consent Approach
- Written informed consent obtained from each participant. Participants must be mentally competent and able to sign written informed consent; must read and understand Dutch. Only adult men (>18 years) are eligible. A subject information and informed consent form document is listed for publication.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 20
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-12-2024
- Latest Decision Or Authorization Date
- 05-12-2024
- Processing Time Days
- 2
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- urology
- Principal Investigator Name
- I.J. de Jong
- Principal Investigator Email
- i.j.de.jong@umcg.nl
- Contact Person Name
- I.J. de Jong
- Contact Person Email
- i.j.de.jong@umcg.nl
- Site Name
- Sint Antonius Ziekenhuis Stichting
- Department Name
- Urology
- Principal Investigator Name
- J.J.H. Beck
- Principal Investigator Email
- j.beck@antoniusziekenhuis.nl
- Contact Person Name
- J.J.H. Beck
- Contact Person Email
- j.beck@antoniusziekenhuis.nl
Sponsor
Primary sponsor
- Full Name
- Universitair Medisch Centrum Groningen
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- [68Ga]FAPI-46
- Active Substance
- (S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- INTRAVENOUS INJECTION
- Maximum Dose
- 200 MBq (max daily); 40 µg (max total)
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