Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
10 participants
OBSERVATIONAL
2025-02-01
2026-12-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Ga-68 Dolacga PET scan
Contrast 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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202409045MIND
Identifier Type: -
Identifier Source: org_study_id
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