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Not yet recruiting NCT06792097

Ga-68 Dolacga PET Scan in HCC Under RFA

— Observational Hepatocellular Carcinoma (HCC) Radiofrequency Ablation PET Scan Computed Tomography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ga-68 Dolacga PET scan.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC), Radiofrequency Ablation, PET Scan, Computed Tomography. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Role of Ga-68 Dolacga PET Scan in Patients With Hepatocellular Carcinoma Under Radiofrequency Ablation

Overview

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.

Interventions

  • Diagnostic test 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.

Primary outcome measures

  • Patient liver reserve capacity before and after radiofrequency ablation therapy [Time frame: 2 years]

Eligibility criteria

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:
  • A single tumor > 5 cm, or multiple tumors > 3 cm.
  • Diffuse hepatocellular carcinoma.
  • Vascular invasion (e.g., portal vein obstruction).
  • Extrahepatic tumor spread.
  • Early-stage liver cancer (BCLC A stage):
  • Contraindications for radiofrequency ablation (RFA).
  • Target lesions previously treated with local therapies, including surgical resection, percutaneous ethanol injection (PEI), or liver transplantation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06792097 · 202409045MIND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗