Overview
Sponsor-declared trial summary
Lymphatic Imaging
To evaluate the feasibility of contrast enhanced ultrasound in visualizing the superficial lymphatic vessels
Key facts
- Sponsor
- Kuopio University Hospital
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Decision date (initial)
- 2024-12-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519077-19-01
- EudraCT number
- 2018-004389-33
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To evaluate the feasibility of contrast enhanced ultrasound in visualizing the superficial lymphatic vessels
Secondary objectives 1
- Compare the visualization of the lymphatic vessels in CEUS, MRI lymphangiography and traditional lymphoscintigraphy
Conditions and MedDRA coding
Lymphatic Imaging
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- -
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-519077-19-00 | Contrast enhanced ultrasound a novel technique in lymphatic imaging - A prospective study | Kuopio University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Volunteer
- Breast cancer patient
Exclusion criteria 1
- Egg protein allergy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Visualization of the superficial lymphatic vessels after the injection of the ultrasound contrast agent
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Sonazoid 8 mikroliter per ml pulver og væske til injeksjonsvæske, dispersjon
PRD1970323 · Product
- Active substance
- Perflubutane
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INTRADERMAL INJECTION
- Max daily dose
- 2 µl microlitre(s)
- Max total dose
- 2 µl microlitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08DA06 — -
- Marketing authorisation
- 11-8225
- MA holder
- GE HEALTHCARE AS
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kuopio University Hospital
- Sponsor organisation
- Kuopio University Hospital
- Address
- Puijonlaaksontie 2, P. O. Box 1777 P. O. Box 1777
- City
- Kuopio
- Postcode
- 70210
- Country
- Finland
Scientific contact point
- Organisation
- Kuopio University Hospital
- Contact name
- Olli Lahtinen
Public contact point
- Organisation
- Kuopio University Hospital
- Contact name
- Olli Lahtinen
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 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Contrast enhanced ultrasound a novel technique in lymphatic imaging A Prospective study | 1 |
| Recruitment arrangements (for publication) | Contrast enhanced ultrasound a novel technique in lymphatic imaging A Prospective study | 1 |
| Subject information and informed consent form (for publication) | Suostumus tutkimukseen | 1 |
| Subject information and informed consent form (for publication) | Tiedote_CEUS | 1 |
| Subject information and informed consent form (for publication) | Tiedote_CEUS_vapaaehtoiset | 1 |
| Subject information and informed consent form (for publication) | Tiedote_CEUS+MRI | 1 |
| Subject information and informed consent form (for publication) | Tiedote_SLN_CEUS | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Sonazoid-Package-Insert-Singapore_Aug2021 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-22 | Finland | Acceptable 2024-12-03
|
2024-12-04 |