About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A single liver tumor, ≤ 2 cm, classified as BCLC stage 0 (very early stage).
Tumors ≤ 3 in number, each ≤ 3 cm, or a single tumor ≤ 5 cm, classified as BCLC stage A (early stage) liver cancer.
ECOG performance status of 0.
Age ≥ 18 years.
Disqualifiers
A single tumor > 5 cm, or multiple tumors > 3 cm.
Diffuse hepatocellular carcinoma.
Vascular invasion (e.g., portal vein obstruction).
Extrahepatic tumor spread.
Trial population
Patients with hepatocellular carcinoma (BCLC stage 0 and stage A) undergo radiofrequency ablation (RFA) treatment
Trial design
Cohort
Prospective
Treatments tested in this trial
Ga-68 Dolacga PET scan
Diagnostic testContrast Name: Nuclear Medicine Dolacga (Lyophilized product for the preparation of gallium Ga68 Dolacga injection). Active Ingredient, Dosage, Route: NOTA-Hexa lactoside (INER038), 40 micrograms, IV injection. PET Imaging Schedule: Before radiofrequency ablation therapy, one month after ablation therapy, and follow-up every three months thereafter.
Treatment groups
Trial outcomes
Primary outcomes
Patient liver reserve capacity before and after radiofrequency ablation therapy
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
Locations
Sponsors and contacts
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