Clinical trial • Not applicable • Other
Perflubutane for Lymphatic imaging
Not applicable trial of Perflubutane for Lymphatic imaging. 100 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Lymphatic imaging
- Trial Stage
- Not applicable
- Drug Modality
- Diagnostic agent
Key dates
- Initial CTIS Submission Date
- 22-11-2024
- First CTIS Authorization Date
- 04-12-2024
Trial design
Not applicable trial across 1 site in Finland.
- Target Sample Size
- 100
Eligibility
Recruits 100 No vulnerable populations selected (isVulnerablePopulationSelected: false). Subject information and informed consent form documents are listed in the application documents (multiple "Subject information and informed consent form" files). No assent procedures or special vulnerable-population consent handling are specified..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Subject information and informed consent form documents are listed in the application documents (multiple "Subject information and informed consent form" files). No assent procedures or special vulnerable-population consent handling are specified.
Inclusion criteria
- {"criterion_text":"-Volunteer"}
- {"criterion_text":"-Breast cancer patient"}
Exclusion criteria
- {"criterion_text":"-Egg protein allergy"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Visualization of the superficial lymphatic vessels after the injection of the ultrasound contrast agent","definition_or_measurement_approach":"Assessment of visualization of superficial lymphatic vessels after injection of ultrasound contrast agent; secondary objectives indicate comparison of visualization between CEUS, MRI lymphangiography and traditional lymphoscintigraphy."}
Recruitment
- Planned Sample Size
- 100
- Recruitment Window Months
- 120
- Consent Approach
- Informed consent documents are provided (multiple "Subject information and informed consent form" documents listed). Consent is to be obtained from participants; no mention of assent, age-specific consent forms, or languages is provided in the available data.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 100
Finland
- Earliest CTIS Part Ii Submission Date
- 21-11-2024
- Latest Decision Or Authorization Date
- 04-12-2024
- Processing Time Days
- 13
- Number Of Sites
- 1
- Number Of Participants
- 100
Sites
- Site Name
- Kuopio University Hospital
- Department Name
- Department of Radiology
- Contact Person Name
- Olli Lahtinen
- Contact Person Email
- olli.lahtinen@pshyvinvointialue.fi
Sponsor
Primary sponsor
- Full Name
- Kuopio University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- Sonazoid 8 mikroliter per ml pulver og væske til injeksjonsvæske, dispersjon
- Active Substance
- Perflubutane
- Modality
- Diagnostic agent
- Routes Of Administration
- INTRADERMAL INJECTION
- Route
- Intradermal injection
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 11-8225; authorisationCountryCode: NO)
- Starting Dose
- 2 µl
- Maximum Dose
- 2 µl
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