Overview
Sponsor-declared trial summary
Metastatic or unresectable solid malignancies. Standard of care treatment options must not be available or not be considered feasible. Patients must have a primary tumor or metastasis that is suitable for HIFU-HT treatment.
Key facts
- Sponsor
- Universitair Medisch Centrum Utrecht
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Jul 2024 → ongoing
- Decision date (initial)
- 2024-02-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Metastatic or unresectable solid malignancies. Standard of care treatment options must not be available or not be considered feasible. Patients must have a primary tumor or metastasis that is suitable for HIFU-HT treatment.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Utrecht
- Sponsor organisation
- Universitair Medisch Centrum Utrecht
- Address
- Heidelberglaan 100
- City
- Utrecht
- Postcode
- 3584 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Clinical trial management imaging
Public contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Clinical trial management imaging
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 24 | 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 | 2024-07-26 | 2024-08-13 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-10 | Netherlands | Acceptable with conditions 2024-02-28
|
2024-02-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-08 | Netherlands | Acceptable with conditions 2024-02-28
|
2024-07-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-21 | Netherlands | Acceptable 2025-11-06
|
2025-11-06 |