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

National Atomic Research Institute, Taiwan

Status

Not yet enrolling

Conditions

Hepatic Carcinoma

Treatments

Drug: Ga-68 Dolacga Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06182865

INER-V09DX-proton

Details and patient eligibility

About

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.

Full description

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).

Enrollment

10 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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