Overview
Sponsor-declared trial summary
Vesicoureteral reflux
Diagnostic accoracy of CEVUS in detecting vesicoureteral reflux
Key facts
- Sponsor
- Turku University Hospital
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Male Urogenital Diseases [C12]
- Decision date (initial)
- 2024-11-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518974-15-01
- EudraCT number
- 2021-006371-42
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
Diagnostic accoracy of CEVUS in detecting vesicoureteral reflux
Conditions and MedDRA coding
Vesicoureteral reflux
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518974-15-00 | Diagnosing Vesicoureteric Reflux in Children by Direct Isotope Cystography and Contrast Enhanced Voiding Ultrasonography | Turku University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- under 6 years old patients who have had at least 2 culture positive urinary tract infections
Exclusion criteria 1
- abnormal bladder function posterior uretral valves
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Vesicoureteral reflux yes or no
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SonoVue 8 microlitres/mL powder and solvent for dispersion for injection
PRD451459 · Product
- Active substance
- Sulfur Hexafluoride
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INTRAVESICAL USE
- Max daily dose
- 0.2 % (V/V) percent volume/volume
- Max total dose
- 0.2 % (V/V) percent volume/volume
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08DA05 — SULFUR HEXAFLUORIDE
- Marketing authorisation
- EU/1/01/177/002
- MA holder
- BRACCO INTERNATIONAL BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Ultra-TechneKow FM, 2,15–43,00 GBq, radionuklidigeneraattori
PRD5961924 · Product
- Active substance
- Technetium (99MTC)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVESICAL USE
- Max daily dose
- 40 MBq megabecquerel(s)
- Max total dose
- 40 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09FX01 — TECHNETIUM (99MTC) PERTECHNETATE
- Marketing authorisation
- 11275
- MA holder
- CURIUM NETHERLANDS B.V.
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Turku University Hospital
- Sponsor organisation
- Turku University Hospital
- Address
- Kiinamyllynkatu 4-8
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Turku University Hospital
- Contact name
- Pediatric surgery
Public contact point
- Organisation
- Turku University Hospital
- Contact name
- Pediatric surgery
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Tutkimussuunnitelma | 1 |
| Recruitment arrangements (for publication) | Tiedote tutkittavan vanhemmalle | 1 |
| Subject information and informed consent form (for publication) | Suostumuslomake | 1 |
| Subject information and informed consent form (for publication) | Tiedote tutkittavan vanhemmalle | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | valmisteyhteenveto_Generaattori_Ultra-TechneKow | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | valmisteyhteenvetoSonoVue SPC | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-04 | Finland | Acceptable 2024-11-15
|
2024-11-18 |