Overview
Sponsor-declared trial summary
breast cancer
To assess the sensitivity and specificity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid).
Key facts
- Sponsor
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04], Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Jul 2025 → ongoing
- Decision date (initial)
- 2024-12-09
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the sensitivity and specificity of CEUS for intra-operative SN localization compared to the gold standard (99mTc nanocolloid).
Secondary objectives 3
- Time required to localize the SNs using CEUS.
- Intraoperative usability of the CEUS-system.
- Using CEUS to predict if SNs are malignant
Conditions and MedDRA coding
breast cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Aged 18 years or older
- Patient has been diagnosed with cancer in the skin (melanoma), breast or head & neck (including melanoma of head and neck area)
- In case of a melanoma: it should be located in the limbs or head and neck area
- Scheduled for a surgical SN procedure at the NKI-AvL
- Patient provides written informed consent
Exclusion criteria 3
- Pregnancy
- Any known clinically significant acute hypersensitivity reaction to the study medication, such as eggs or egg products
- Other contra-indications for Sonazoid contrast agent, including arteriovenous cardiac or pulmonary shunt, serious coronary arterial disease and serious pulmonary disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- sensitivity and specificity of the CEUS SN localization method
Secondary endpoints 3
- time required to localize the SNs using CEUS in minutes
- usability of the CEUS system using a system-usability-score (SUS)
- sensitivity and specificity of using CEUS to predict if SNs are malignant
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
- INTRATUMORAL USE
- Max daily dose
- 6 ml millilitre(s)
- Max total dose
- 6 ml millilitre(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
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Sponsor organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Address
- Plesmanlaan 121
- City
- Amsterdam
- Postcode
- 1066 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Contact name
- Dr. Q.R.J.G. Tummers
Public contact point
- Organisation
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Contact name
- Dr. Q.R.J.G. Tummers
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 91 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2025-07-07 | 2025-09-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-515259-40-00 redacted | 1.4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements N24CUS | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF N24CUS_redacted | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Sonazoid | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-09 | Netherlands | Acceptable 2024-12-09
|
2024-12-09 |