Diagnostic contribution of XENETIX® CT PERFUSION in pre-therapeutical assessment of hepatocellular carcinoma. - Hepatic CT perfusion

Guerbet0 个研究点目标入组 83 人开始时间: 2011年10月24日最近更新: 2014年11月24日

研究概览

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•- 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 used for the study 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

•- Subjects who have undergone prior TACE (TransArterial Chemo Embolization), prior RFA (Radio Frequency Ablation) or prior SIRT (Selected Internal Radio Therapy) within two years 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 >120µmol/l) or estimated creatinine clearance < 30 ml/min as calculated by the Cockcroft and Gault formula or e-GFR < 30ml/min/1.73m²)
•- 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).

发起方