Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05007548
Other study ID # INER-V09DX-02
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Recruiting NCT03253250 - The Investigation of Peginterferon Alfa-2a on the RFS of the Subjects With HCC Who Have Been Treated by Resection Phase 4
Terminated NCT01760616 - Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy Phase 4
Active, not recruiting NCT04682847 - Radiotherapy With Iron Oxide Nanoparticles (SPION) on MR-Linac for Primary & Metastatic Hepatic Cancers
Not yet recruiting NCT03149523 - Exhaustive Genetic and Immunological Characterization of Colon, Kidney and Liver Tumors N/A
Recruiting NCT05009550 - ESP Block on Patient Outcomes in Patients With Liver Tumor Undergoing Radiofrequency Ablation N/A
Recruiting NCT06342414 - An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer
Recruiting NCT03132740 - Impact of Three-dimensional Visualization on Operation Strategy and Complications for Complex Hepatic Carcinoma
Completed NCT03164382 - Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib in Advanced Hepatocellular Carcinoma Phase 3
Completed NCT03572582 - Transarterial Chemoembolization in Combination With Nivolumab Performed for Intermediate Stage Hepatocellular Carcinoma Phase 2
Completed NCT04266548 - Arterial Base Fluorescence Segmental Positive Staining N/A
Recruiting NCT03013712 - A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer Phase 1/Phase 2
Recruiting NCT01350726 - Functional-three-dimensional Reconstruction of Liver by 99MTc-GSA-SPECT Scan N/A
Completed NCT06245798 - Liver Resection for Patients With Hepatocellular Carcinoma and Clinically Significant Portal Hypertension
Recruiting NCT06311396 - Development of a Neuronal Microscope N/A
Recruiting NCT04220944 - Combined Locoregional Treatment With Immunotherapy for Unresectable HCC. Phase 1
Completed NCT02352935 - Percutaneous Irreversible Electroporation for Unresectable Hepatic Carcinoma in Poor Liver Function N/A
Completed NCT02332551 - Percutaneous Irreversible Electroporation to Treat Liver Cancer Close to the Gallbladder N/A
Completed NCT02834780 - Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma Phase 1
Not yet recruiting NCT06182865 - A Study of Ga-68 Dolacga to Evaluate Liver Reserve Function in Patients With HCC Before and After Proton Therapy N/A
Completed NCT03163186 - Transradial Versus Transfemoral Arterial Access in Liver Cancer Embolization: Randomized Trial to Assess Patient Outcomes and Satisfaction (BEST ACCESS Trial). N/A