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

National Atomic Research Institute, Taiwan

Status and phase: Completed; Phase 2

Conditions: Hepatic Carcinoma

Treatments: Drug: Ga68-Dolacga Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05007548

INER-V09DX-02

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Ga68-Dolacga Injection

Experimental group

Description:

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

Treatment:

Drug: Ga68-Dolacga Injection