NCT06792097

Brief Summary

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. 1.How to assess treatment response and liver function changes in hepatocellular carcinoma patients undergo RFA via Ga-68 Dolacga PET scan?
  2. 2.Compared with computed tomography (CT) scans, how effective is Ga-68 Dolacga PET scan for treatment response assessment?
  3. 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?
  4. 4.Undergo Ga-68 Dolacga PET scans and computed tomography before and one month after RFA treatment, followed by monitoring every three months thereafter.
  5. 5.Total liver functional volume and residual liver functional volume are obtained from Ga-68 Dolacga PET scan

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Feb 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Feb 2025Dec 2026

First Submitted

Initial submission to the registry

January 19, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

January 19, 2025

Last Update Submit

January 19, 2025

Conditions

Hepatocellular Carcinoma (HCC)Radiofrequency AblationPET ScanComputed TomographyDeep Learning

Keywords

Hepatocellular carcinomaRadiofrequency ablationGa-68 Dolacga PET scanLiver functionNeural networkRadiomics

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Interventions

Ga-68 Dolacga PET scanDIAGNOSTIC_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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hepatocellular carcinoma (BCLC stage 0 and stage A) undergo radiofrequency ablation (RFA) treatment

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Ja-Der Liang, MD, phD

CONTACT

+886 0223123456jdliangntu@ntu.edu.tw

Geng-Hao Bai, MD

CONTACT

+886953861233b101105010@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2025

First Posted

January 24, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share