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

Hepatic Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05007548
• Other study ID #: INER-V09DX-02
• Status: Completed
• Phase: Phase 2
• Start date: December 14, 2021
• Est. completion date: November 20, 2023

Study information

• Verified date: December 2023
• Source: National Atomic Research Institute, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatic Carcinoma

Intervention

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

Locations

Country	Name	City	State
Taiwan	Linkon Chang Gung Memorial Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
National Atomic Research Institute, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)."	visit 2 (Day 1)
Primary	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 (%)."	within 7 days prior to Day 1
Primary	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 %.	within 7 days prior to Day 1
Primary	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 %.	visit 2 (Day 1)
Primary	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.	from pre-dose to Day 1
Primary	Correlation of the remnant volume rate determined by CTV 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.	from pre-dose to Day 1
Primary	Correlation of the ICGR15 with the 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), Child-Pugh classification (Class A to Class C), MELD score.	from pre-dose to Day 1
Secondary	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.	from pre-dose to Day 1
Secondary	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.	from pre-dose to Day 1
Secondary	Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure		from pre-dose to 14±2 days post dose
Secondary	Number of subjects with body temperature abnormalities		from pre-dose to 14±2 days post dose
Secondary	Number of subjects with clinically significant changes in Heart Rate		from pre-dose to 14±2 days post dose
Secondary	Number of subjects reporting clinically significant changes in serum biochemical tests		from pre-dose to 14±2 days post dose
Secondary	Number of subjects reporting clinically significant changes in hematological tests		from pre-dose to 14±2 days post dose
Secondary	Number of subjects reporting clinically significant changes in urinalysis		from pre-dose to 14±2 days post dose
Secondary	Number of subjects with clinically significant changes in electrocardiogram(ECG)	The ECG parameters include: PR interval (milliseconds), QTc interval (milliseconds), QRS duration (milliseconds)	from pre-dose to 14±2 days post dose
Secondary	Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	All laboratory abnormalities which are compared with screening values and out of the reference range will be considered as AE and will be assessed its relationship to the study drug. Any ECG changes including ECG waveform will be assessed as AE(s) and will be followed to assess whether they resolved and when they resolved.	14 days
Secondary	Incidence of posthepatectomy liver failure (PHLF)		on or after postoperative day 5 (POD 5)
Secondary	Severity grading of PHLF as defined by the International Study Group of Liver Surgery (ISGLS)	Subjects diagnosed with PHLF are classified as grade A, grade B or grade C based on its severity.	on or after postoperative day 5 (POD 5)
Secondary	Comparison of CTV and Ga68-Dolacga PET parameters in patients with PHLF	Following parameters will be compared: liver reserve obtained from CTV vs liver reserve obtained from Ga68-Dolacga PET; FLRV% vs FLRF%	on or after postoperative day 5 (POD 5)