Overview

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

Status:
Not yet recruiting
Trial end date:
2024-12-30
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Atomic Research Institute, Taiwan
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