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

NCT05007548 | Completed Phase 2 FDA Drug

• 1 other identifier: INER-V09DX-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Carcinoma

Outcome Measures

Primary Outcomes (7)

• 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)

• 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

• 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

• 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)

• 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

• 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

• 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 Outcomes (13)

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

  from pre-dose to Day 1

• Correlation of the ICGR15 with the fibrosis indices

  from pre-dose to Day 1

• Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure

  from pre-dose to 14±2 days post dose

• Number of subjects with body temperature abnormalities

  from pre-dose to 14±2 days post dose

• Number of subjects with clinically significant changes in Heart Rate

  from pre-dose to 14±2 days post dose

Study Arms (1)

Ga68-Dolacga Injection

EXPERIMENTAL

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

Drug: Ga68-Dolacga Injection

Interventions

Ga68-Dolacga Injection DRUG

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

Also known as: Ga68-INER038

Ga68-Dolacga Injection

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Pregnant women, lactating or breast-feeding women;
• Patient who can't be followed up for any reason.

Sponsors & Collaborators

• National Atomic Research Institute, Taiwan: lead

Study Sites (1)

Linkon Chang Gung Memorial Hospital

Taoyuan, 333423, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Wei-Chen Lee, MD

  Linkon Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 16, 2021
• Study Start: December 14, 2021
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)