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Completed

NCT Number: 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

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.

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Key information

Conditions

Hepatic Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Linkon Chang Gung Memorial Hospital

Taoyuan City, 333423, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ga68-Dolacga Injection

Drug

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

Other names: Ga68-INER038

Primary outcomes

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

    Time frame: visit 2 (Day 1)

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

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

    Time frame: within 7 days prior to Day 1

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

  3. Measurement of future liver remnant volume rate (FLRV%)

    Time frame: within 7 days prior to Day 1

    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 %.

  4. Measurement of future liver remnant function rate (FLRF%)

    Time frame: visit 2 (Day 1)

    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 %.

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

    Time frame: from pre-dose to Day 1

    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.

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

    Time frame: from pre-dose to Day 1

    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.

  7. Correlation of the ICGR15 with the conventional liver function tests

    Time frame: from pre-dose to Day 1

    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 outcomes

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

    Time frame: from pre-dose to Day 1

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

  2. Correlation of the ICGR15 with the fibrosis indices

    Time frame: from pre-dose to Day 1

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

  3. 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

  4. Number of subjects with body temperature abnormalities

    Time frame: from pre-dose to 14±2 days post dose

  5. Number of subjects with clinically significant changes in Heart Rate

    Time frame: from pre-dose to 14±2 days post dose

  6. Number of subjects reporting clinically significant changes in serum biochemical tests

    Time frame: from pre-dose to 14±2 days post dose

  7. Number of subjects reporting clinically significant changes in hematological tests

    Time frame: from pre-dose to 14±2 days post dose

  8. Number of subjects reporting clinically significant changes in urinalysis

    Time frame: from pre-dose to 14±2 days post dose

  9. Number of subjects with clinically significant changes in electrocardiogram(ECG)

    Time frame: from pre-dose to 14±2 days post dose

    The ECG parameters include: PR interval (milliseconds), QTc interval (milliseconds), QRS duration (milliseconds)

  10. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 14 days

    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.

  11. Incidence of posthepatectomy liver failure (PHLF)

    Time frame: on or after postoperative day 5 (POD 5)

  12. Severity grading of PHLF as defined by the International Study Group of Liver Surgery (ISGLS)

    Time frame: on or after postoperative day 5 (POD 5)

    Subjects diagnosed with PHLF are classified as grade A, grade B or grade C based on its severity.

  13. Comparison of CTV and Ga68-Dolacga PET parameters in patients with PHLF

    Time frame: on or after postoperative day 5 (POD 5)

    Following parameters will be compared:

    • liver reserve obtained from CTV vs liver reserve obtained from Ga68-Dolacga PET
    • FLRV% vs FLRF%

Sponsors and collaborators

Lead sponsor

National Atomic Research Institute, Taiwan

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2021
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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