Ga-68 Dolacga PET Scan in HCC Under RFA (HCC; RFA)

National Taiwan University

Status: Not yet enrolling

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

Treatments: Diagnostic Test: Ga-68 Dolacga PET scan

Study type: Observational

Funder types: Other

Identifiers

NCT06792097

202409045MIND

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.