Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ga68-Dolacga Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ga68-Dolacga Injection
- description
- Ga68-Dolacga will be administered via iv bolus injection followed by a whole-body PET/CT scan for liver reserve evaluation.
- interventionNames
- Drug: Ga68-Dolacga Injection
Primary outcomes (7)
- measure
- Measurement of liver reserve obtained from Ga68-Dolacga PET performed in patients scheduled surgical operation (Percentage of injection dose, %ID)
- timeFrame
- visit 2 (Day 1)
- description
- The liver reserve obtained from Ga68-Dolacga PET is expressed in "percentage of injection dose (%ID)."
- measure
- Measurement of liver reserve obtained from CTV performed in patients scheduled surgical operation (Remnant volume rate (%))
- timeFrame
- within 7 days prior to Day 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
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