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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

Primary Purpose

Hepatic Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Ga68-Dolacga Injection
Sponsored by
Institute of Nuclear Energy Research, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatic Carcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Linkon Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ga68-Dolacga Injection

Arm Description

Ga68-Dolacga will be administered via iv bolus injection followed by a whole-body PET/CT scan for liver reserve evaluation.

Outcomes

Primary Outcome Measures

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)."
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 (%)."
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 %.
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 %.
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.
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.
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.

Secondary Outcome Measures

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.
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.
Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure
Number of subjects with body temperature abnormalities
Number of subjects with clinically significant changes in Heart Rate
Number of subjects reporting clinically significant changes in serum biochemical tests
Number of subjects reporting clinically significant changes in hematological tests
Number of subjects reporting clinically significant changes in urinalysis
Number of subjects with clinically significant changes in electrocardiogram(ECG)
The ECG parameters include: PR interval (milliseconds), QTc interval (milliseconds), QRS duration (milliseconds)
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.
Incidence of posthepatectomy liver failure (PHLF)
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.
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%

Full Information

First Posted
July 29, 2021
Last Updated
July 11, 2022
Sponsor
Institute of Nuclear Energy Research, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05007548
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Nuclear Energy Research, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ga68-Dolacga Injection
Arm Type
Experimental
Arm Description
Ga68-Dolacga will be administered via iv bolus injection followed by a whole-body PET/CT scan for liver reserve evaluation.
Intervention Type
Drug
Intervention Name(s)
Ga68-Dolacga Injection
Other Intervention Name(s)
Ga68-INER038
Intervention Description
Ga68-Dolacga Injection, 2.0±1.0 mCi, single dose, iv bolus
Primary Outcome Measure Information:
Title
Measurement of liver reserve obtained from Ga68-Dolacga PET performed in patients scheduled surgical operation (Percentage of injection dose, %ID)
Description
The liver reserve obtained from Ga68-Dolacga PET is expressed in "percentage of injection dose (%ID)."
Time Frame
visit 2 (Day 1)
Title
Measurement of liver reserve obtained from CTV performed in patients scheduled surgical operation (Remnant volume rate (%))
Description
The liver reserve obtained from computer tomography volumetry (CTV) is expressed in "remnant volume rate (%)."
Time Frame
within 7 days prior to Day 1
Title
Measurement of future liver remnant volume rate (FLRV%)
Description
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
Title
Measurement of future liver remnant function rate (FLRF%)
Description
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)
Title
Correlation of the percentage of injection dose (%ID) in liver determined by Ga68-Dolacga PET with conventional liver function tests
Description
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
Title
Correlation of the remnant volume rate determined by CTV with conventional liver function tests
Description
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
Title
Correlation of the ICGR15 with the conventional liver function tests
Description
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.
Time Frame
from pre-dose to Day 1
Secondary Outcome Measure Information:
Title
Correlation of the percentage of injection dose (%ID) in liver determined by Ga68-Dolacga PET with the fibrosis indices
Description
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
Title
Correlation of the ICGR15 with the fibrosis indices
Description
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
Title
Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure
Time Frame
from pre-dose to 14±2 days post dose
Title
Number of subjects with body temperature abnormalities
Time Frame
from pre-dose to 14±2 days post dose
Title
Number of subjects with clinically significant changes in Heart Rate
Time Frame
from pre-dose to 14±2 days post dose
Title
Number of subjects reporting clinically significant changes in serum biochemical tests
Time Frame
from pre-dose to 14±2 days post dose
Title
Number of subjects reporting clinically significant changes in hematological tests
Time Frame
from pre-dose to 14±2 days post dose
Title
Number of subjects reporting clinically significant changes in urinalysis
Time Frame
from pre-dose to 14±2 days post dose
Title
Number of subjects with clinically significant changes in electrocardiogram(ECG)
Description
The ECG parameters include: PR interval (milliseconds), QTc interval (milliseconds), QRS duration (milliseconds)
Time Frame
from pre-dose to 14±2 days post dose
Title
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
14 days
Title
Incidence of posthepatectomy liver failure (PHLF)
Time Frame
on or after postoperative day 5 (POD 5)
Title
Severity grading of PHLF as defined by the International Study Group of Liver Surgery (ISGLS)
Description
Subjects diagnosed with PHLF are classified as grade A, grade B or grade C based on its severity.
Time Frame
on or after postoperative day 5 (POD 5)
Title
Comparison of CTV and Ga68-Dolacga PET parameters in patients with PHLF
Description
Following parameters will be compared: liver reserve obtained from CTV vs liver reserve obtained from Ga68-Dolacga PET FLRV% vs FLRF%
Time Frame
on or after postoperative day 5 (POD 5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Subjects without ascites or with controllable ascites; Serum total bilirubin level < 2.0 mg/dL; Written informed consent must be obtained before any assessment is performed. Male or female subjects aged 20 or above, inclusive, at date of consent. Exclusion Criteria: Presence of distant metastases; A body weight loss of >10% during the 6 months before operation; Presence of seriously impaired function of vital organs due to respiratory, renal, or heart disease; Cholangiocarcinoma; General PET exclusion criteria; Pregnant women, lactating or breast-feeding women; Patient who can't be followed up for any reason.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei-Hui Wang, PhD
Phone
+886 34711400
Ext
7162
Email
mhwang@iner.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Chen Lee, MD
Organizational Affiliation
Linkon Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linkon Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
333423
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Chen Lee, MD
Phone
+886 33281200
Ext
3366
Email
weichen@adm.cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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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

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