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

NCT ID: NCT06182865

Last Updated: 2023-12-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2024-12-30

Brief 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.

Detailed Description

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).

Conditions

Hepatic Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ga-68 Dolacga Injection

Ga-68 Dolacga Injection, 2.0±1.0 mCi, single dose, iv bolus

Group Type: EXPERIMENTAL

Ga-68 Dolacga Injection

Intervention Type: DRUG

Ga-68 Dolacga will be administered via iv bolus injection followed by a whole-body PET/CT scan for liver reserve evaluation.

Interventions

Ga-68 Dolacga Injection

Ga-68 Dolacga will be administered via iv bolus injection followed by a whole-body PET/CT scan for liver reserve evaluation.

Intervention Type: DRUG

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)
• Can't follow our follow-up schedule because of any reason

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Atomic Research Institute, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bing-Shen Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Linkon Chang Gung Memorial Hospital

Locations

Linkon Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Countries

Taiwan

Central Contacts

Mei-Hui Wang, PhD

Role: CONTACT

Phone: +886-3-4711400

Email: mhwang@nari.org.tw

Facility Contacts

Bing-Shen Huang, MD

Role: primary

Other Identifiers

INER-V09DX-proton

Identifier Type: -

Identifier Source: org_study_id