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.
Conditions
Interventions
Product Name: [68GA]NODAGA-RGD
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 68GA-NODAGA-RGD
Current Sponsor code: 68GA-NODAGA-RGD
Other descriptive name: 68GA-NODAGA-RGD
Concentrat
Sponsors
Medizinische Universität Innsbruck, Abteilung für Nuklearmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate safety and tolerability of [68Ga]NODAGA-RGD in patients with liver disease. To evaluate if tracer accumulation changes after systemic (Sorafenib) or locoablative (TACE, RFA) therapies. Results obtained by PET can be compared to results obtained by CT/MRI to test if PET is superior in diagnosis of vital tumor parenchyma as compared to CT/MRI. Furthermore we want to determine [68Ga]NODAGA-RGD whole body biodistribution (organ exposure to substance) and pharmacokinetics and the radiation dosimetry of [68Ga]NODAGA-RGD (organ exposure to radiation) ;Primary end point(s): Tracer accumulation in HCC expressed as ratio of standardised uptake values (SUV) within HCC regions divided by SUV in liver tissue unaffected by HCC;Timepoint(s) of evaluation of this end point: At baseline PET scan.;Main Objective: The primary objective is to evaluate accumulation of [68Ga]NODAGA-RGD tracer in HCC compared to the surrounding liver parenchyma and to correlate the tumor volume measured by [68Ga]NODAGA-RGD-PET to the tumor volume measured by CT/MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in tracer accumulation after anti-tumor therapies (Sorafenib, TACE or RFA). ;Timepoint(s) of evaluation of this end point: A maximum of 3 PET scans between month 3 and 12 under anti-tumor therapy. | — |
Countries
Austria
Contacts
Public ContactArmin Finkenstedt
Medizinische Universität Innsbruck, Abteilung für Gastroenterologie und Hepatologie
Outcome results
None listed