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Not yet recruitingNCT06792097HCC; RFAUpdated Jan 24, 2025

Ga-68 Dolacga PET Scan in HCC Under RFA

An observational study in Hepatocellular Carcinoma (HCC), Radiofrequency Ablation and PET Scan, sponsored by National Taiwan University Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-24.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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
Read the 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.

02

Conditions studied

  • Hepatocellular Carcinoma (HCC)
  • Radiofrequency Ablation
  • PET Scan
  • Computed Tomography
  • Deep Learning

Keywords

  • Hepatocellular carcinoma
  • Radiofrequency ablation
  • Ga-68 Dolacga PET scan
  • Liver function
  • Neural network
  • Radiomics
03

In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's planned enrollment of 10 is below the median of 200 across 769 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,608 studies on the registry; 573 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Browse National Taiwan University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • Diagnostic testGa-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.

06

What researchers measure

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

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2025; primary completion for Dec 2026, 22 months later.

Of 273 non-industry observational studies under Carcinoma, Hepatocellular, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 112. This study's planned 22 months is below that.

Counting every sponsor, half of 313 studies reached it within 50 months; a quarter within 32 and three quarters within 98.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2025
First posted
Jan 24, 2025
StartEst.
Feb 1, 2025
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Jan 24, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06792097
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jan 24, 2025
Start date
Feb 1, 2025 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 24, 2025

Study contacts

Ja-Der Liang, MD, phD
Contact
jdliangntu@ntu.edu.tw
+886 0223123456 ext. 266551
Geng-Hao Bai, MD
Contact
b101105010@gmail.com
+886953861233

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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