Actively Recruiting
[68Ga]Ga-PSMA PET/CT in Hepatocellular Carcinoma: Impact of Multiparametric Dynamic Whole-body Imaging and Kinetic Modeling.
Led by Nantes University Hospital · Updated on 2025-10-07
40
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the use of multiparametric dynamic whole-body \[68Ga\]Ga-PSMA PET/CT imaging in newly diagnosed HCC patients or in HCC patients with recent suspicion of refractory, residual, or recurrent disease.
CONDITIONS
Official Title
[68Ga]Ga-PSMA PET/CT in Hepatocellular Carcinoma: Impact of Multiparametric Dynamic Whole-body Imaging and Kinetic Modeling.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Patient aged 218 years or older
- For cohort A: Histologically proven HCC or meeting radiological criteria and scheduled for biopsy
- For cohort B: Known HCC requiring new diagnostic imaging for suspected refractory, residual, or recurrent disease
- Presence of at least one morphological evaluable lesion by mRECIST 1.1 using contrast CT or MRI
- ECOG performance status of 0 to 2
- Child-Pugh class A liver function
- Life expectancy of at least 6 months as determined by the investigator
- Affiliated with or beneficiary of the National Health Service
- Consent to use double-barrier contraception after [68Ga]Ga-PSMA injection (6 months for women and their partners, 3 months for men and their partners)
You will not qualify if you...
- Known allergy to PSMA-11, any excipient, derivative, or radiographic contrast agents
- Need for emergency surgery due to ruptured or bleeding HCC
- Radioembolization within 3 months before joining the study
- Cardiac disease classified as New York Heart Association class III or IV
- Major surgery within 4 weeks before enrollment
- Other cancers unless fully treated and no recurrence for 2 years (except certain skin or cervical cancers)
- Uncontrolled or significant medical, psychiatric, or surgical conditions that could risk safety or compliance
- Pregnant or breastfeeding women (pregnancy test required for women of childbearing potential)
- Patients under guardianship, trusteeship, or judicial protection
AI-Screening
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Trial Site Locations
Total: 2 locations
1
HU Paris Nord APHP
Clichy, France
Not Yet Recruiting
2
CHU de Nantes
Nantes, France
Actively Recruiting
Research Team
C
Clément BAILLY
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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