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Hepatic CarcinomaPhase 2NCT05007548

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

A Phase 2 study testing Ga68-Dolacga Injection in people with Hepatic Carcinoma, run by National Atomic Research Institute, Taiwan at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hepatic Carcinoma
What is being tested?
Ga68-Dolacga Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTaiwan
Study dates
14 Dec 2021to 20 Nov 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Linkon Chang Gung Memorial Hospital

    Taoyuan City, 333423

Other trials in Taiwan

About this study

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

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.

Read the 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).

Being tested
Ga68-Dolacga Injection
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ga68-Dolacga InjectionDrug

    Also called Ga68-INER038

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

Study groups in NCT05007548
Study groupRoleWhat they receive
Ga68-Dolacga InjectionExperimentalGa68-Dolacga will be administered via iv bolus injection followed by a whole-body PET/CT scan for liver reserve evaluation.
Receives: Drug: Ga68-Dolacga Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)."

    Measured: visit 2 (Day 1)

  2. 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 (%)."

    Measured: within 7 days prior to Day 1

  3. 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 %.

    Measured: within 7 days prior to Day 1

  4. 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 %.

    Measured: visit 2 (Day 1)

  5. 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.

    Measured: from pre-dose to Day 1

  6. 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.

    Measured: from pre-dose to Day 1

  7. 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.

    Measured: from pre-dose to Day 1

Secondary outcomes (13)

  1. 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.

    Measured: from pre-dose to Day 1

  2. 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.

    Measured: from pre-dose to Day 1

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

    Measured: from pre-dose to 14±2 days post dose

  4. Number of subjects with body temperature abnormalities

    Measured: from pre-dose to 14±2 days post dose

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

    Measured: from pre-dose to 14±2 days post dose

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

    Measured: from pre-dose to 14±2 days post dose

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

    Measured: from pre-dose to 14±2 days post dose

  8. Number of subjects reporting clinically significant changes in urinalysis

    Measured: from pre-dose to 14±2 days post dose

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

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

    Measured: from pre-dose to 14±2 days post dose

  10. 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.

    Measured: 14 days

  11. Incidence of posthepatectomy liver failure (PHLF)

    Measured: on or after postoperative day 5 (POD 5)

  12. 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.

    Measured: on or after postoperative day 5 (POD 5)

  13. 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%

    Measured: on or after postoperative day 5 (POD 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2021
  2. Study start14 Dec 2021
  3. Primary completion20 Nov 2023
  4. Study completion20 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05007548
Sponsor's protocol ID
INER-V09DX-02
Status last verified
Dec 2023
First submitted
29 Jul 2021
Last updated
13 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ga68-Dolacga Injection in people with Hepatic Carcinoma, run by National Atomic Research Institute, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05007548.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.

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