A Study of Ga-68 Dolacga to Evaluate Liver Reserve Function in Patients With HCC Before and After Proton Therapy

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.

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.

This trial will enroll 10 eligible subjects. All subjects will provide informed consent before any study procedures are performed. Screening procedures (visit 1) will occur within 21 days prior to imaging visit (visit 2) and will include: inclusion/exclusion criteria check, pregnancy test (if applicable), vital signs, laboratory tests, electrocardiogram (ECG) and establishment of baseline characteristics. Primovist MRI will occur within 14 days prior to imaging visit (visit 2) and 1 week after imaging visit (visit 4), and will be performed according to standard procedure of study site.

The baseline characteristics include medical/medication history, fibrosis index, Child-Pugh score and classification, MELD score, liver oncology diagnosis, tumor size, preoperative treatments (portal vein embolization, transarterial chemoembolization, transarterial embolization or biliary drainage), existence of thrombosis (portal vein thrombosis or hepatic vein thrombosis). The liver tissue fibrosis index FIB-4 will be measured to assess the morphological changes.

During the imaging session (visit 2, Day 1; visit 4, Day 84±3), a catheter will be placed for intravenous (IV) administration of Ga-68 Dolacga. Subjects will receive an iv bolus injection of 2.0±1.0 mCi Ga-68 Dolacga. A PET/CT scan will be kinetically performed for 60 minutes immediately after IV injection.

The measurement of liver reserve is the primary endpoints of this study and measurement will be evaluated by Ga-68 Dolacga PET. The measurement of liver reserve will be performed at visit 2 and visit 4 of this study for all subjects. Adverse events will be continuously monitored during the imaging session.

Two follow-up visits (visit 3 at Day 7±2 and visit 5 at Day 91±2) will be conducted to confirm subject well-being and to collect information about any new adverse events (if any).

Eligibility Criteria:
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