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

• Conditions: Subjects diagnosed for HCC and planned for surgery (tumorectomy, sectionectomy, segmentectomy, lobectomy or transplantation).; MedDRA version: 18.1Level: LLTClassification code 10019830Term: Hepatocellular carcinoma resectableSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2011-002609-31-DE
• Lead Sponsor: Guerbet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-28
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 83

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

- 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified