Subjects diagnosed for HCC and planned for surgery (tumorectomy, sectionectomy, segmentectomy, lobectomy or transplantation). MedDRA version: 18.1 Level: LLT Classification code 10019830 Term: Hepatocellular carcinoma resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: XENETIX 350
Product Name: Xenetix 350
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IOBITRIDOL
CAS Number: 136949-58-1
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Guerbet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female, adult subjects (having reached legal majority age – 18 years old for European subjects, 20 years old for Korean subjects). - Subjects diagnosed for HCC and planned for surgery (tumorectomy, sectionectomy, segmentectomy, lobectomy or transplantation) within a timeframe of 30 days between first imaging procedure and surgery. - Female subjects must be surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea) or must have a documented negative urine pregnancy test at screening. - Subjects able to understand and having provided their written informed consent to participate in the trial. - Subjects with health insurance (according to the local regulatory requirements) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 68 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - Subjects who have undergone prior TACE (Trans Arterial Chemo Embolization), prior RFA (Radio Frequency Ablation) or prior SIRT (Selected Internal Radio Therapy) within one year before inclusion. - Subjects with known severe adverse drug reaction or contraindication to the investigational product. - Subjects having received any MR or X-Ray contrast medium within 24 hours prior to administration of investigational product. - Subjects presenting with known severe renal failure (elevated serum creatinine (>1.5 mg/dl or > 120 µmol/l) or estimated creatinine clearance < 30 ml/min as calculated by the Cockcroft and Gault formula or e-GFR < 30ml/min/1.73m²) - Subjects with hyperthyroidism. - Any condition which, based on the investigator's clinical judgement, would prevent the subjects from completing all trial assessments and visits (e.g.: mental or physical incapacity, language comprehension, geographical localisation, etc…). - Subjects under guardianship and/or inability or unwillingness to cooperate with the requirements of this trial. - Breast feeding or pregnant subjects - Subjects previously included in this trial - Subjects having participated in any investigational drug study within 30 days prior the study inclusion or already included in another clinical trial involving an Investigational Medicinal Product (IMP).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prospectively determine the diagnostic value of Xenetix®-CT perfusion for the discrimination between well-differentiated HCC and moderately/poorly differentiated HCC (off-site assessment). Histopathology will be used as the gold standard for the evaluation of HCC grading;Secondary Objective: (1) To evaluate diagnostic value of Xenetix®-CT perfusion for the discrimination between well-differentiated HCC and moderately/poorly differentiated HCC (on-site assessment) (2) To evaluate the correlation between CT perfusion parameters (on-site and off-site assessments) and: - histopathology data for HCC disease - vascular invasion according to histopathology - AFP levels - mid-term outcomes of subjects with HCC after a one year follow-up from surgery (3) To compare CT perfusion, triple phase CT and MRI images in terms of: - number of lesions - localization of lesions - size of lesions - characterization of lesions - Sensitivity, specificity, positive and negative predictive values for HCC detection and characterization (4) To evaluate the feasibility of a CT perfusion protocol and data post-processing in clinical routine. (5) To assess the clinical tolerance of Xenetix 350 during and immediately after the CT perfusion examination.;Primary end point(s): The primary endpoint is the measurement of three CT perfusion parameters (Blood Volume (BV), Blood Flow (BF) and Permeability Surface area product (PS)) in two groups of tumors: well differentiated tumors and moderately/poorly differentiated tumors.;Timepoint(s) of evaluation of this end point: Visit: CT perfusion imaging Histology assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): From the intervention phase trial: · On-site evaluation of primary criterion. · Agreement between CT perfusion measurements (BV, BF, PS and ALP, PVP, TLP and HPI) and histopathology findings will be assessed. Histological findings taken into account here are the TNM classification and the following immunohistochemistry parameters HCC phenotype (Glypican-3, HSP70, Glutamine synthetase), microvessel density (CD-31) and angiogenic factors (H1F1alpha, CA-9). Means of each perfusion parameters will be computed within TNM categories or immunohistochemistry grading levels (50%) and compared through analyses of variance (parameters in TNM) and regression analyses (parameters in grading scales). · Agreement between CT perfusion measurements and vascular invasion (histologically proven) will be assessed. Perfusion parameter means will be computed for subjects with and without vascular invasion. Difference between the 2 groups will be tested using Student’s t-test. · Agreement between CT perfusion measurements and fibrosis and necrosis level will be assessed through linear and non-linear regression analyses. · Agreement between CT perfusion measurements and AFP level will be assessed through linear and non-linear regression analyses. · CT perfusion, CE-CT and MRI examinations will be compared for the number of additional foci/lesion(s) observed and their location. The analysis of variance will be used for testing average number of lesion and the Chi square for testing the independence between imaging examinations and location of lesions. · Sensitivity, specificity, positive and negative predictive values of CT perfusion, contrast enhanced-CT (CE-CT) for HCC detection and characterization will be assessed using MRI findings as reference technique. From the observation phase trial: · The relation between the different perfusion parameters and surgery follow-up will be explored, taken into account the disease evolution and the subject management | — |
Countries
Austria, Germany, Korea, Republic of, Switzerland
Contacts
Public ContactClinical project manager
Guerbet
Outcome results
None listed