Clinical trial NCT05007548: 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
Official title: An Open-label, Comparative Phase II Clinical Trial 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 Among Scheduled Surgery Operation Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatic Carcinoma
Lead sponsor: National Atomic Research Institute, Taiwan
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of liver reserve obtained from Ga68-Dolacga PET performed in patients scheduled surgical operation (Percentage of injection dose, %ID)
timeFrame: visit 2 (Day 1)
measure: Measurement of liver reserve obtained from CTV performed in patients scheduled surgical operation (Remnant volume rate (%))
timeFrame: within 7 days prior to Day 1
measure: Measurement of future liver remnant volume rate (FLRV%)
timeFrame: within 7 days prior to Day 1
measure: Measurement of future liver remnant function rate (FLRF%)
timeFrame: visit 2 (Day 1)
measure: Correlation of the percentage of injection dose (%ID) in liver determined by Ga68-Dolacga PET with conventional liver function tests
timeFrame: from pre-dose to Day 1
measure: Correlation of the remnant volume rate determined by CTV with conventional liver function tests
timeFrame: from pre-dose to Day 1
measure: Correlation of the ICGR15 with the conventional liver function tests
timeFrame: from pre-dose to Day 1
Secondary outcomes:
measure: Correlation of the percentage of injection dose (%ID) in liver determined by Ga68-Dolacga PET with the fibrosis indices
timeFrame: from pre-dose to Day 1
measure: Correlation of the ICGR15 with the fibrosis indices
timeFrame: from pre-dose to Day 1
measure: Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure
timeFrame: from pre-dose to 14±2 days post dose
measure: Number of subjects with body temperature abnormalities
timeFrame: from pre-dose to 14±2 days post dose
measure: Number of subjects with clinically significant changes in Heart Rate
timeFrame: from pre-dose to 14±2 days post dose
measure: Number of subjects reporting clinically significant changes in serum biochemical tests
timeFrame: from pre-dose to 14±2 days post dose
measure: Number of subjects reporting clinically significant changes in hematological tests
timeFrame: from pre-dose to 14±2 days post dose
measure: Number of subjects reporting clinically significant changes in urinalysis
timeFrame: from pre-dose to 14±2 days post dose
measure: Number of subjects with clinically significant changes in electrocardiogram(ECG)
timeFrame: from pre-dose to 14±2 days post dose
measure: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 14 days
measure: Incidence of posthepatectomy liver failure (PHLF)
timeFrame: on or after postoperative day 5 (POD 5)
measure: Severity grading of PHLF as defined by the International Study Group of Liver Surgery (ISGLS)
timeFrame: on or after postoperative day 5 (POD 5)
measure: Comparison of CTV and Ga68-Dolacga PET parameters in patients with PHLF
timeFrame: on or after postoperative day 5 (POD 5)
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Linkon Chang Gung Memorial Hospital
Study officials:
affiliation: Linkon Chang Gung Memorial Hospital
name: Wei-Chen Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: