Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
32
Countries
1
Sites
1
Hepatocellular carcinoma
To determine the diagnostic accuracy of F-18 PSMA-11 PET/CT for the (re)staging of hepatocellular carcinoma (HCC) compared to F-18 FDG PET/CT and F-18 Choline PET/CT.
Key facts
- Sponsor
- Universitair Ziekenhuis Gent
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-08-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Kom Op Tegen Kanker · University Hospital Ghent
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis
To determine the diagnostic accuracy of F-18 PSMA-11 PET/CT for the (re)staging of hepatocellular carcinoma (HCC) compared to F-18 FDG PET/CT and F-18 Choline PET/CT.
Secondary objectives 4
- To compare overall survival and progression-free survival between subjects with PSMA-avid disease versus those with FDG-avid and Choline-avid disease.
- To evaluate tumor-to-background ratios for intrahepatic lesions
- To assess Standard Uptake Value (SUV) parameters for all lesions
- To determine the proportion of subjects with metastatic disease detected by PSMA PET/CT, versus those detected by FDG and Choline PET.
Conditions and MedDRA coding
Hepatocellular carcinoma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Willing and mentally legally capable to provide written informed consent
- 18 years of age or older
- - One of the following clinical scenario’s: • New diagnosis of HCC, confirmed either by biopsy or imaging using EASL/AASLD criteria, with a high risk of metastases indicated by portal invasion or a primary lesion of >5cm diameter. • Known diagnosis of HCC that requires restaging due to unexplained elevated AFP tumor markers, known metastases, impending initiation of immunotherapy, or being on the waiting list for a liver transplant.
- Have either planned or recently undergone (within the past 4 weeks) both F-18 FDG PET/CT and F-18 Choline PET/CT scans as part of their diagnostic or staging workup for one of the above indications.
Exclusion criteria 4
- Known active malignancy other than hepatocellular carcinoma.
- History of prostate cancer
- Active pregnancy
- Possible pregnancy and refusal of urine pregnancy test
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Per-lesion detection rate of F-18 PSMA-11 PET/CT, 60-90 minutes post-injection.
Secondary endpoints 4
- Overall Survival (OS) and Progression-Free Survival (PFS): Measured among subjects with PSMA-avid, FDG-avid, and Choline-avid HCC lesions, measured after completion of the 2 year follow-up for all patients.
- Tumor-to-Background Ratio: Assessed for intrahepatic HCC lesions 60-90 minutes post-injection using F-18 PSMA-11 PET/CT.
- Standard Uptake Value (SUV) Parameters: Analyzed for all HCC lesions detected 60-90 minutes post-injection with F-18 PSMA-11 PET/CT.
- Proportion of subjects with Metastatic HCC: Comparison between those detected by F-18 PSMA-11 PET/CT, F-18 FDG PET, and F-18 Choline PET, 60-90 minutes post-injection.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10247135 · Product
- Active substance
- Gozetotide ALF-18
- Substance synonyms
- AL(18F)PSMA-11, (AL18F)PSMA-HBED
- Other product name
- [18F]PSMA-HBED
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 2.2 MBq/kg megabecquerel(s)/kilogram
- Max total dose
- 2.2 MBq/kg megabecquerel(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- UNIVERSITAIR ZIEKENHUIS GENT
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Ziekenhuis Gent
- Sponsor organisation
- Universitair Ziekenhuis Gent
- Address
- Corneel Heymanslaan 10
- City
- Gent
- Postcode
- 9000
- Country
- Belgium
Scientific contact point
- Organisation
- Universitair Ziekenhuis Gent
- Contact name
- Robbe Waterschoot
Public contact point
- Organisation
- Universitair Ziekenhuis Gent
- Contact name
- Robbe Waterschoot
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 32 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-29 | Belgium | Acceptable 2024-08-23
|
2024-08-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-15 | Belgium | Acceptable 2024-08-23
|
2025-07-15 |