Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
173
Countries
1
Sites
3
Patients with liver tumors that will undergo minimally invasive liver surgery
• To analyze the detection of liver tumors using indocyanine green fluorescence uptake in combination with intraoperative ultrasonography and preoperative imaging test • To develop a machine-learning algorithm to detect liver tumors with indocyanine green by photographic analysis.
Key facts
- Sponsor
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- 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]
- Trial duration
- 10 Jun 2024 → ongoing
- Decision date (initial)
- 2024-02-12
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Stryker Corporation
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
• To analyze the detection of liver tumors using indocyanine green fluorescence uptake in combination with intraoperative ultrasonography and preoperative imaging test
• To develop a machine-learning algorithm to detect liver tumors with indocyanine green by photographic analysis.
Secondary objectives 3
- To study lCG distribution in the liver parenchyma and its correlation with hepatic fibrosis and steatosis
- To describe ICG uptake patterns and their correlation with liver tumors.
- To analyze the 30 and 90 days Comprehensive Complication Index, operation time, conversion to open surgery, length of hospital stay, liver tumor recurrence, readmission and 90-day mortality
Conditions and MedDRA coding
Patients with liver tumors that will undergo minimally invasive liver surgery
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10025630 | Malignant liver tumour resectable | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | LIVERGREEN Phase IV and low intervention clinical trial. Prospective, with no control group
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patients with liver tumors with an indication for minimally invasive surgery, evaluated by the hospital’s multidisciplinary liver tumor board (MDTB).
- Preoperative imaging test (contrast-enhanced liver MRI, multiphasic contrast-enhanced abdominal CT, or contrast-enhanced PET-CT) performed prior to the surgical intervention according to usual clinical practice of each site.
- ≥18 years old
- Absence of exclusion criteria and able to provide consent for data collection and analysis
Exclusion criteria 3
- Emergency surgery
- Patients in which ICG is contraindicated (one condition will be enough for excluding the patient): 1. previous history of iodine hypersensitivity; 2. patients with renal failure (GFR <60 mL/min/1.73 m2); 3 uremic syndrome; 4. clinical hyperthyroidism; 5. autonomic thyroid adenomas; or 6. focal and diffuse autonomic abnormalities of the thyroid gland.
- Previous liver surgery
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Quantify the intraoperative detection of liver tumors using IOUS and ICG
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB14208MIG · Substance
- Active substance
- Indocyanine Green
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 0.2 mg/kg milligram(s)/kilogram
- Max total dose
- 0.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Sponsor organisation
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Address
- Passeig De La Vall D'Hebron 119-129
- City
- Barcelona
- Postcode
- 08035
- Country
- Spain
Scientific contact point
- Organisation
- Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
- Contact name
- Tamara del Río
Public contact point
- Organisation
- Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
- Contact name
- Tamara del Río
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 173 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitari De Girona Doctor Josep Trueta
General Surgery, Avinguda De Franca S/n, 17007, Girona
Hospital Universitari Vall D Hebron
HPB and Transplantation Surgery Unit, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Bellvitge University Hospital
Surgery and Liver Transplant Unit, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
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 |
|---|---|---|---|---|---|
| Spain | 2024-06-10 | 2024-09-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU-CT_2023-508316-27-00 | 10.0 |
| Protocol (for publication) | D1_Protocol_EU-CT_2023-508316-27-00_Cambios aceptados | 12 |
| Protocol (for publication) | D1_Protocol_EU-CT_2023-508316-27-00_Control cambios | 12 |
| Protocol (for publication) | D1_SA 1_Protocol EU-CT_2023-508316-27-00 cambios aceptados | 11.0 |
| Protocol (for publication) | D1_SA 1_Protocol EU-CT_2023-508316-27-00_cambios marcados | 11.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SA 1_SIS and ICF for patients_cambios aceptados | 2.0 |
| Subject information and informed consent form (for publication) | L1_SA 1_SIS and ICF for patients_cambios marcados | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for patients | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF General_Spanish_Cambios aceptados | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF General_Spanish_Control Cambios | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Verde de Indocianina | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ESP EU-CT_2023-508316-27-00 | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ EU-CT_2023-508316-27-00_Spanish_cambios aceptados | 12 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ EU-CT_2023-508316-27-00_Spanish_Control cambios | 12 |
| Synopsis of the protocol (for publication) | D1_SA 1_Protocol synopsis ESP EU-CT_2023-508316-27-00_cambios aceptados | 11.0 |
| Synopsis of the protocol (for publication) | D1_SA 1_Protocol synopsis ESP EU-CT_2023-508316-27-00_cambios marcados | 11.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-28 | Spain | Acceptable 2024-02-12
|
2024-02-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-06 | Spain | Acceptable 2024-05-03
|
2024-05-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-27 | Spain | Acceptable 2025-05-29
|
2025-05-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-29 | Spain | Acceptable 2025-05-30
|
2025-05-30 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-25 | Spain | Acceptable | 2025-08-29 |