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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

NCT ID: NCT05007548

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-14

Study Completion Date

2023-11-20

Brief Summary

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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

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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).

Conditions

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Hepatic Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ga68-Dolacga Injection

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

Group Type EXPERIMENTAL

Ga68-Dolacga Injection

Intervention Type DRUG

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

Interventions

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Ga68-Dolacga Injection

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

Intervention Type DRUG

Other Intervention Names

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Ga68-INER038

Eligibility Criteria

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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;
6. Pregnant women, lactating or breast-feeding women;
7. Patient who can't be followed up for any reason.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Atomic Research Institute, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei-Chen Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Linkon Chang Gung Memorial Hospital

Locations

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Linkon Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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INER-V09DX-02

Identifier Type: -

Identifier Source: org_study_id