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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:
Participants will:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ga-68 Dolacga PET scan | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient liver reserve capacity before and after radiofrequency ablation therapy | Expressed as percentage of injected dose (%ID) and standardized uptake value (SUV).
| 2 years |
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Inclusion Criteria:
Patients with hepatocellular carcinoma (BCLC stage 0 and stage A) eligible for radiofrequency ablation (RFA) treatment exhibit the following characteristics:
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.
Exclusion Criteria:
Intermediate (BCLC B stage) and advanced (BCLC C stage) liver cancer patients:
Early-stage liver cancer (BCLC A stage):
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Patients with hepatocellular carcinoma (BCLC stage 0 and stage A) undergo radiofrequency ablation (RFA) treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ja-Der Liang, MD, phD | Contact | +886 0223123456 | 266551 | jdliangntu@ntu.edu.tw |
| Geng-Hao Bai, MD | Contact | +886953861233 | b101105010@gmail.com |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |