Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
119
Countries
1
Sites
3
Colorectal liver metastases
Key facts
- Sponsor
- Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 25 Jun 2024 → ongoing
- Decision date (initial)
- 2024-05-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504572-25-00
- WHO UTN
- U1111-1290-1350
- ClinicalTrials.gov
- NCT06630624
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Colorectal liver metastases
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC
- Sponsor organisation
- Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC
- Contact name
- A.J.M. van den Broek
Public contact point
- Organisation
- Amsterdam UMC
- Contact name
- Amsterdam UMC - Location VUmc
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 119 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Amsterdam UMC
Radiology and Nuclear Medicine, De Boelelaan 1117, 1081 HV, Amsterdam
Noordwest Ziekenhuisgroep Stichting
Interventieradioloog, Radiologie, Wilhelminalaan 12, 1815 JD, Alkmaar
Universitair Medisch Centrum Utrecht
Department of Radiology - Imaging and Cancer Division, Heidelberglaan 100, 3584 CX, Utrecht
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 | 2024-06-25 | 2024-07-12 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-24 | Netherlands | Acceptable 2024-05-06
|
2024-05-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-07-26 | Netherlands | Acceptable 2024-05-06
|
2024-07-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-23 | Netherlands | Acceptable 2024-10-24
|
2024-10-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-11 | Netherlands | Acceptable 2025-03-05
|
2025-03-05 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-05-02 | Netherlands | Acceptable 2025-06-10
|
2025-06-11 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-22 | Netherlands | Acceptable 2025-12-16
|
2026-01-07 |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-04-22 | Netherlands | Acceptable 2026-05-20
|
2026-05-28 |