to Assess the Accuracy and Reliability of the Ga68-Dolacga Positron Emission Tomography Compared to Computer Tomography Volumetry and Indocyanine Green Retention Test for Measurement of Liver Reserve

National Atomic Research Institute, Taiwan30 enrolled

Overview

This is a phase 2 open-labeled study to compare the Ga68-Dolacga positron emission tomography with computer tomography volumetry and indocyanine green retention test for measurement of liver reserve among scheduled surgery operation patients.

This is a phase 2 open-labeled study to compare the Ga68-Dolacga positron emission tomography with computer tomography volumetry (CTV) and indocyanine green retention test (ICGR15) for measurement of liver reserve among scheduled surgery operation patients. The goal is to enroll 30 eligible subjects scheduled for surgery operation. CTV and ICGR15 will occur within 7 days prior to the imaging visit for all eligible subjects. During the imaging visit (visit 2, Day 1), subjects will receive an iv bolus injection of 2.0±1.0 mCi Ga68-Dolacga Injection. Ga68-Dolacga PET will be kinetically performed 60 minutes immediately after iv injection. Two follow-up visits (visit 3 at Day 7±2 and visit 4 at Day 14±2) will be conducted to confirm subject well-being and to collect information about any new adverse events (if any).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Hepatic Carcinoma

Interventions

Ga68-Dolacga InjectionDRUG

Ga68-Dolacga Injection, 2.0±1.0 mCi, single dose, iv bolus

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Scheduled operation subjects with diagnosed hepatic carcinoma. The eligibility criteria for operation refer to protocol Appendix II: Diagnosis and Treatment Guidelines for Hepatocellular Carcinoma in Chang Gung Memorial Hospital; 2. Subjects without ascites or with controllable ascites; 3. Serum total bilirubin level \< 2.0 mg/dL; 4. Written informed consent must be obtained before any assessment is performed. 5. Male or female subjects aged 20 or above, inclusive, at date of consent. Exclusion Criteria: 1. Presence of distant metastases; 2. A body weight loss of \>10% during the 6 months before operation; 3. Presence of seriously impaired function of vital organs due to respiratory, renal, or heart disease; 4. Cholangiocarcinoma; 5. General PET exclusion criteria; 6. Pregnant women, lactating or breast-feeding women; 7. Patient who can't be followed up for any reason.

Locations (1)

Linkon Chang Gung Memorial Hospital

Taoyuan City, Taiwan

Outcomes

Primary Outcomes

Measurement of liver reserve obtained from Ga68-Dolacga PET performed in patients scheduled surgical operation (Percentage of injection dose, %ID)

The liver reserve obtained from Ga68-Dolacga PET is expressed in "percentage of injection dose (%ID)."

Time frame: visit 2 (Day 1)

Measurement of liver reserve obtained from CTV performed in patients scheduled surgical operation (Remnant volume rate (%))

The liver reserve obtained from computer tomography volumetry (CTV) is expressed in "remnant volume rate (%)."

Time frame: within 7 days prior to Day 1

Measurement of future liver remnant volume rate (FLRV%)

The future liver remnant volume rate (FLRV%) is calculated by dividing the future remnant liver volume by the total functional liver volume from CTV and expressed as %.

Time frame: within 7 days prior to Day 1

Measurement of future liver remnant function rate (FLRF%)

The future liver remnant function rate (FLRV%) is calculated by dividing the uptake in the future remnant liver volume by the uptake in the total liver volume from Ga68-Dolacga PET and expressed as %.

Time frame: visit 2 (Day 1)

Correlation of the percentage of injection dose (%ID) in liver determined by Ga68-Dolacga PET with conventional liver function tests

The conventional liver function tests parameters include alanine aminotransferase (U/L), aspartate aminotransferase (U/L), total bilirubin (mg/dL), direct bilirubin (mg/dL), gamma-glutamyl transpeptidase (U/L), total protein (g/dL), albumin/globulin ratio, albumin (g/dL), prothrombin time/International Normalized Ratio (PT/INR), platelet count (×10\^3/μL), ICGR15 (%), Child-Pugh classification (Class A to Class C), MELD score.

Time frame: from pre-dose to Day 1

Correlation of the remnant volume rate determined by CTV with conventional liver function tests

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Correlation of the percentage of injection dose (%ID) in liver determined by Ga68-Dolacga PET with the fibrosis indices

The fibrosis indices include liver stiffness measurement (kPa) determined by Fibroscan and the Fibrosis-4 (FIB-4) index.

Time frame: from pre-dose to Day 1

Correlation of the ICGR15 with the fibrosis indices

The fibrosis indices include liver stiffness measurement (kPa) determined by Fibroscan and the Fibrosis-4 (FIB-4) index.

Time frame: from pre-dose to Day 1

Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure