Ga-68 Dolacga PET Scan in HCC Under RFA

Not yet recruiting

• Conditions: Hepatocellular Carcinoma (HCC); PET Scan; Computed Tomography; Deep Learning; Radiofrequency Ablation

• Registration Number: NCT06792097
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

This study aims to investigate the use of Ga-68 Dolacga PET scan technology to assess treatment response and liver function changes in patients of early-stage liver cancer receiving RFA. The main questions it aims to answer are:

1. How to assess treatment response and liver function changes in hepatocellular carcinoma patients undergo RFA via Ga-68 Dolacga PET scan?

2. Compared with computed tomography (CT) scans, how effective is Ga-68 Dolacga PET scan for treatment response assessment?

3. What is the correlation between Ga-68 Dolacga PET scan findings and patient treatment outcomes by tracking liver function and tumor recurrence after RFA?

Participants will:

1. Undergo Ga-68 Dolacga PET scans and computed tomography before and one month after RFA treatment, followed by monitoring every three months thereafter.

2. Total liver functional volume and residual liver functional volume are obtained from Ga-68 Dolacga PET scan

Detailed Description

This study aims to investigate the use of Ga-68 Dolacga PET scan technology to assess treatment response and liver function changes in patients of early-stage liver cancer receiving RFA. This study also compares the results of Ga-68 Dolacga PET scans with computed tomography (CT) scans and evaluate the correlation between Ga-68 Dolacga PET scan findings and patient treatment outcomes by tracking liver function and tumor recurrence after RFA.

This study adopts a prospective clinical trial design, enrolling patients with early-stage liver cancer and undergoing RFA treatment. Clinical data, laboratory results, serum, biopsy tissues for pathology and relevant imaging findings are collected for analysis. Participants undergo Ga-68 Dolacga PET scans and CT before and one month after RFA treatment, followed by monitoring every three months thereafter. Quantitative analysis utilizes region of interest techniques to measure standardized uptake values (SUV). Total liver functional volume and residual liver functional volume are obtained from Ga-68 Dolacga PET scan injection dose percentages and SUV values. Changes in liver storage capacity as determined by Ga-68 Dolacga PET scans are evaluated and correlated with traditional laboratory liver function tests and imaging evaluations.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-19
• Study First Submitted QC: 2025-01-19
• Last Update Submitted: 2025-01-19
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Study Start: 2025-02-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients with hepatocellular carcinoma (BCLC stage 0 and stage A) eligible for radiofrequency ablation (RFA) treatment exhibit the following characteristics:

  1. A single liver tumor, ≤ 2 cm, classified as BCLC stage 0 (very early stage).
  2. Tumors ≤ 3 in number, each ≤ 3 cm, or a single tumor ≤ 5 cm, classified as BCLC stage A (early stage) liver cancer.
  3. ECOG performance status of 0.
  4. Age ≥ 18 years.

Exclusion Criteria

• Intermediate (BCLC B stage) and advanced (BCLC C stage) liver cancer patients:

  1. A single tumor > 5 cm, or multiple tumors > 3 cm.
  2. Diffuse hepatocellular carcinoma.
  3. Vascular invasion (e.g., portal vein obstruction).
  4. Extrahepatic tumor spread.

• Early-stage liver cancer (BCLC A stage):

  1. Contraindications for radiofrequency ablation (RFA).
  2. Target lesions previously treated with local therapies, including surgical resection, percutaneous ethanol injection (PEI), or liver transplantation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient liver reserve capacity before and after radiofrequency ablation therapy	2 years	Expressed as percentage of injected dose (%ID) and standardized uptake value (SUV).; 1. Correlation with patients' baseline characteristics, laboratory data, tumor characteristics; 2. Compared with ICG test; 3. Compared with computed tomography; 4. Correlation with patients' overall survival, progression free survival, objective response rate