Clinical trial · Interventional
A Study of Ga-68 Dolacga to Evaluate Liver Reserve Function in Patients With HCC Before and After Proton Therapy
A Prospective Study of Ga-68 Dolacga Scintigraphy to Evaluate Liver Reserve Function in Patients With Hepatocellular Carcinoma Before and After Proton Therapy
NCT06182865CI-TRIAL-00072592unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 single-center, prospective, open-labeled, single-arm, interventional study to evaluate liver reserve and tumor response using Ga-68 Dolacga positron emission tomography and the safety of the investigational product in patients with hepatocellular carcinoma before and after proton therapy.
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 |
|---|---|---|---|
| Ga-68 Dolacga Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ga-68 Dolacga Injection
- description
- Ga-68 Dolacga Injection, 2.0±1.0 mCi, single dose, iv bolus
- interventionNames
- Drug: Ga-68 Dolacga Injection
Primary outcomes (2)
- measure
- Measurement of liver reserve obtained from the Ga-68 Dolacga PET performed in HCC patients before proton therapy.
- timeFrame
- Visit 2 (Day 1)
- description
- The liver reserve parameters obtained from Ga-68 Dolacga PET is expressed in "percentage of injection dose (%ID) and standard uptake value, (SUV)."
- measure
- Measurement of liver reserve obtained from the Ga-68 Dolacga PET performed in HCC patients after proton therapy.
- timeFrame
- Visit 4 (Day 84±3)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with hepatocellular carcinoma and scheduled to have the PBT. * 20\~80 years old * Performance status: ECOG 0-1 * Child-Pugh class A Exclusion Criteria: * Massive or uncontrolled ascites * Concurrent with other malignancy * Under pregnancy or breastfeeding * With distant metastasis * Allergic to investigational drug(s) or similar drug(s)/ formulation(s); * Known hypersensitivity to PRIMOVIST * Acute or chronic severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m\^2) * General PET and MRI exclusion criteria * Can't follow our follow-up schedule because of any reason
References
Publications (0)
Data not yet available
No reference posted for this study.