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

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Nuclear Energy Research, Taiwan

Criteria

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.