Clinical Trial Page

Summary
EudraCT Number:2021-000270-28
Sponsor's Protocol Code Number:NL75171.058.20
National Competent Authority:Netherlands - Competent Authority
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2021-10-22
Trial results
A. Protocol Information
A.1Member State ConcernedNetherlands - Competent Authority
A.2EudraCT number2021-000270-28
A.3Full title of the trial
Selective Indocyanine Green Injection of a Segmental Hepatic Artery Followed by Near-Infrared Fluorescence
Guided Anatomical Liver Resection: A Feasibility Study
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Selective Indocyanine Green Injection of a Segmental Hepatic Artery Followed by Near-Infrared Fluorescence Guided Anatomical Liver Resection: A Feasibility Study
A.3.2Name or abbreviated title of the trial where available
SELECT Study
A.4.1Sponsor's protocol code numberNL75171.058.20
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorLeiden University Medical Center
B.1.3.4CountryNetherlands
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportLeiden University Medical Center
B.4.2CountryNetherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationLeiden University Medical Center
B.5.2Functional name of contact pointo.d.bijlstra@lumc.nl
B.5.3 Address:
B.5.3.1Street AddressAlbinusdreef 2
B.5.3.2Town/ cityLeiden
B.5.3.3Post code2333 ZA
B.5.3.4CountryNetherlands
B.5.6E-mailo.d.bijlstra@lumc.nl
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Verdye
D.2.1.1.2Name of the Marketing Authorisation holderDiagnostic Green GmbH Otto-Hahn-Str.20 85609 Aschheim-Dornach Duitsland
D.2.1.2Country which granted the Marketing AuthorisationNetherlands
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameIndocyanine green
D.3.4Pharmaceutical form Powder for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraarterial use
Intravenous use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Lipiodol
D.2.1.1.2Name of the Marketing Authorisation holderGuerbet BP 57400 95943 Roissy CdG Cedex Frankrijk
D.2.1.2Country which granted the Marketing AuthorisationNetherlands
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.4Pharmaceutical form Solution for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntraarterial use
Intravenous use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Hepatocellular carcinoma, hepatic adenoma, intrahepatic cholangiocarcinoma, colorectal liver metastases
E.1.1.1Medical condition in easily understood language
Primary malignant liver tumor
Non-malignant liver tumor
Malignant secondary liver tumor
E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
MedDRA Classification
E.1.3Condition being studied is a rare disease Yes
E.2 Objective of the trial
E.2.1Main objective of the trial
The primary objective is to investigate the feasibility of using intra-arterial ICG preoperatively to allow for liver segment visualization during anatomical liver resection.
E.2.2Secondary objectives of the trial
1. To investigate the dosage which provides sufficient contrast index of ICG in the liver segment compared to normal liver tissue.
2. To investigate the optimal timing of administration of the ICG-mixture without being washed out of a liver segment.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1.Scheduled for open or laparoscopic anatomical liver resection;
2.Patients aged over 18 years old;
3.Has the ability to communicate well with the investigator in Dutch or English and willing to comply with the study design;
4.Signed informed consent prior to any study-mandated procedure.
E.4Principal exclusion criteria
1.Previous major abdominal surgery
2.Known allergy or history of adverse reaction to ICG, lipiodol, gel foam, iodine or iodine contrast agents;
3.Child Pugh B or C
4.Portal hypertension or portal vein thrombosis
5.eGFR: <30; in case of eGFR 30-59 metformin should be stopped >48 hours prior to Lipiodol administration and continued >48 hours after Lipiodol administration
6.Hyperthyroidism or a benign thyroid tumor;
7.Pregnant or breastfeeding women;
8.Scheduled for palliative surgery or terminally ill
9.Any condition that the investigator considers to be potentially jeopardizing the patient’s well-being or the study objectives (following a detailed medical history and physical examination);
10.Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;
11.Emergency surgery.
E.5 End points
E.5.1Primary end point(s)
The feasibility of using intra-arterial ICG and embolization preoperatively to allow for liver segment visualization during anatomical liver resection. Visibility will be measured using a contrast ratio between normal liver parenchyma and ICG colored liver parenchyma. A signal-to-background ratio of 1.6 provides sufficient contrast for an anatomical resection and will therefore be used as endpoint.
E.5.1.1Timepoint(s) of evaluation of this end point
Evaluation of the SBR will take place after each patient. After each two patients either dose and/or time interval will be changed.
E.5.2Secondary end point(s)
1.Time ideal window between intervention radiology and operation will be increased after every two successful liver segment visualizations (contrast ratio of ≥1.6). The endpoint for this parameter is 24 hours, and will be confirmed in 4 consecutive patients.
E.5.2.1Timepoint(s) of evaluation of this end point
Evaluation of the SBR will take place after each patient. After each two patients either dose and/or time interval will be changed.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised No
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial12
E.8.3 The trial involves single site in the Member State concerned Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
LVLS
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months6
E.8.9.1In the Member State concerned days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 6
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 6
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations No
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception No
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state12
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
According to standard of care.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2022-06-30
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2021-10-18
P. End of Trial
P.End of Trial StatusOngoing
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