Clinical trial • Phase IV • Oncology

INDOCYANINE GREEN for Resectable malignant liver tumour

Phase IV trial of INDOCYANINE GREEN for Resectable malignant liver tumour. open-label, none/not specified (prospective, with no control group).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Resectable malignant liver tumour
Trial Stage
Phase IV
Drug Modality
Diagnostic agent

Key dates

Initial CTIS Submission Date
28-11-2023
First CTIS Authorization Date
12-02-2024

Trial design

open-label, none/not specified (prospective, with no control group) Phase IV trial across 3 sites in Spain.

Open Label
Yes
Comparator
None/Not specified (prospective, with no control group)
Target Sample Size
173
Trial Duration For Participant
90

Eligibility

Recruits 173 No vulnerable populations selected. Participants must be able to provide informed consent for data collection and analysis (see inclusion criterion and available Subject Information Sheet and Informed Consent Form). All participants are adults (≥18 years) so assent is not applicable; consent is provided by the participant..

Vulnerable Population
No vulnerable populations selected. Participants must be able to provide informed consent for data collection and analysis (see inclusion criterion and available Subject Information Sheet and Informed Consent Form). All participants are adults (≥18 years) so assent is not applicable; consent is provided by the participant.

Inclusion criteria

  • {"criterion_text":"- Patients with liver tumors with an indication for minimally invasive surgery, evaluated by the hospital’s multidisciplinary liver tumor board (MDTB).\n- 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.\n- ≥18 years old\n- Absence of exclusion criteria and able to provide consent for data collection and analysis"}

Exclusion criteria

  • {"criterion_text":"- Emergency surgery\n- Patients in which ICG is contraindicated (one condition will be enough for excluding the patient): 1.\tprevious 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.\n- Previous liver surgery"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Quantify the intraoperative detection of liver tumors using IOUS and ICG","definition_or_measurement_approach":"Detection quantified intraoperatively using intraoperative ultrasonography (IOUS) combined with indocyanine green (ICG) fluorescence imaging (no further measurement details provided in the record)."}

Recruitment

Planned Sample Size
173
Recruitment Window Months
36
Consent Approach
Participants must provide informed consent; subject information sheet and informed consent form are available (L1_SIS and ICF documents). Participants are adults (≥18 years) so no assent procedures described; consent provided directly by the participant.

Geography

Total Number Of Sites
3
Total Number Of Participants
173

Spain

Earliest CTIS Part Ii Submission Date
07-11-2023
Latest Decision Or Authorization Date
29-08-2025
Processing Time Days
661
Number Of Sites
3
Number Of Participants
173

Sites

Site Name
Bellvitge University Hospital
Department Name
Surgery and Liver Transplant Unit
Contact Person Name
Laura Lladó Garriga
Site Name
Hospital Universitari Vall D Hebron
Department Name
HPB and Transplantation Surgery Unit
Contact Person Name
Martín Huerta García
Contact Person Email
martin.huerta@vallhebron.cat
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
General Surgery
Contact Person Name
Santiago Lópe-Ben

Sponsor

Primary sponsor

Full Name
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Third parties

  • {"country":"","full_name":"Stryker Corporation","duties_or_roles":"Monetary support","organisation_type":""}

Investigational products

Investigational Product Name
INDOCYANINE GREEN
Active Substance
INDOCYANINE GREEN
Modality
Diagnostic agent
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
0.5 mg/kg

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