Clinical trial • Phase IV • Nephrology
Sulfur hexafluoride for Vesicoureteral reflux
Phase IV trial of Sulfur hexafluoride for Vesicoureteral reflux.
Overview
- Trial Therapeutic Area
- Nephrology
- Trial Disease
- Vesicoureteral reflux
- Trial Stage
- Phase IV
- Drug Modality
- Diagnostic agent|Radiopharmaceutical
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 04-11-2024
- First CTIS Authorization Date
- 18-11-2024
Trial design
Ultra-TechneKow FM (technetium-99m pertechnetate) - product name 'Ultra-TechneKow FM, 2,15–43,00 GBq, radionuklidigeneraattori'; reported max dose 40 MBq (dose unit MBq); route: intravesical use. (Comparator indicated in productRoleGroup 'Comparator'.)-controlled Phase IV trial across 1 site in Finland.
- Comparator
- Ultra-TechneKow FM (technetium-99m pertechnetate) - product name 'Ultra-TechneKow FM, 2,15–43,00 GBq, radionuklidigeneraattori'; reported max dose 40 MBq (dose unit MBq); route: intravesical use. (Comparator indicated in productRoleGroup 'Comparator'.)
- Target Sample Size
- 100
Eligibility
Recruits 100 paediatric patients.
- Vulnerable Population
- Participants are children (under 6 years old). The record shows 'isVulnerablePopulationSelected': false. Documents listed include 'Tiedote tutkittavan vanhemmalle' (information to the child's parent) and 'Suostumuslomake' (subject information and informed consent form) indicating consent is sought from parents/legal guardians. No explicit mention of assent handling is provided.
Inclusion criteria
- {"criterion_text":"- under 6 years old patients who have had at least 2 culture positive urinary tract infections"}
Exclusion criteria
- {"criterion_text":"- abnormal bladder function posterior uretral valves"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Vesicoureteral reflux yes or no","definition_or_measurement_approach":"Assessment of presence of vesicoureteral reflux (yes/no); primary objective related to diagnostic accuracy of CEVUS in detecting vesicoureteral reflux."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 96
- Consent Approach
- Informed consent is to be obtained from parents/legal guardians. Documents in the record include 'Tiedote tutkittavan vanhemmalle' (information to the child's parent) and 'Suostumuslomake' (subject information and informed consent form). No explicit mention of assent from minors or available languages is provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 100
Finland
- Earliest CTIS Part Ii Submission Date
- 04-11-2024
- Latest Decision Or Authorization Date
- 18-11-2024
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- Turku University Hospital
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Hanna-Reeta Viljamaa
- Principal Investigator Email
- hanna-reeta.viljamaa@tyks.fi
- Contact Person Name
- Hanna-Reeta Viljamaa
- Contact Person Email
- hanna-reeta.viljamaa@tyks.fi
Sponsor
Primary sponsor
- Full Name
- Turku University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- SonoVue 8 microlitres/mL powder and solvent for dispersion for injection
- Active Substance
- Sulfur hexafluoride
- Modality
- Diagnostic agent
- Routes Of Administration
- Intravesical use
- Route
- Intravesical use
- Authorisation Status
- Marketing authorised (EU MA number EU/1/01/177/002)
- Maximum Dose
- 0.2 % (V/V)
- Investigational Product Name
- Ultra-TechneKow FM, 2,15–43,00 GBq, radionuklidigeneraattori
- Active Substance
- Technetium (99mTc) (pertechnetate)
- Modality
- Radiopharmaceutical
- Routes Of Administration
- Intravesical use
- Route
- Intravesical use
- Authorisation Status
- Marketing authorised (marketing authorisation number 11275, country FI)
- Maximum Dose
- 40 MBq
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