[68GA]NODAGA-RGD-PET FOR THE DIAGNOSIS OF HEPATOCELLULAR CARCINOMA AND THE ASSESSMENT OF TREATMENT RESPONSE

Phase 1

• Conditions: This trial investigates a new tracer substance for PET scan of hepatocellular carcinoma in patients with liver disease. The condition investigated is a hepatocellular carcinoma in patients with liver cirrhosis. In a subset of patients, the PET scan will be repeated during tumor specific therapies to evaluate changes in tracer accumulation after therapy.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2013-003741-42-AT
• Lead Sponsor: Medizinische Universität Innsbruck, Abteilung für Nuklearmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-06
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Yet untreated HCC due to liver cirrhosis Child Pugh class A or class B. The diagnosis of HCC hast to be confirmed by multiphasic CT or MRI according to EASL/EORTC guidelines.
• Written informed consent
• Age 18 or above
• In women, pregnancy must be excluded and contraception must be performed

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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

• Decompensated liver cirrhosis Child Pugh class C
• Uncontrolled complications of portal hypertension (refractory ascites, advanced hepatic encephalopathy or large esophageal varices)
• Advanced renal insufficiency with an eGFR below 30 ml/min

Study & Design

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