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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of multiparametric dynamic whole-body [68Ga]Ga-PSMA PET/CT imaging in patients newly diagnosed with hepatocellular carcinoma (HCC) or those with recent suspicion of refractory, residual, or recurrent disease. The study aims to assess how this imaging technique performs diagnostically and to explore kinetic modeling in this patient population. Participants receive a dynamic whole-body [68Ga]Ga-PSMA PET/CT scan as the investigational procedure. This involves the administration of [68Ga]Ga-PSMA-11 as a radiation-based imaging agent. The study does not mention multiple treatment groups or comparators and focuses on detailed imaging acquisition and analysis. During the study, participants undergo imaging assessments at baseline and follow-up evaluations over six months to measure diagnostic performance, comfort during the procedure, and compare dynamic versus static imaging approaches. Researchers will collect kinetic parameters and evaluate the imaging results at both lesion and patient levels. The total study involvement includes baseline imaging and follow-up assessments within a six-month period to monitor outcomes and safety.
CONDITIONS
Brief 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 6 18 years
- For cohort A: patient with HCC histologically proven or who meet radiological criteria and are scheduled for biopsy
- For cohort B: patient with known HCC requiring a new diagnostic imaging workup for suspected refractory, residual or recurrent disease
- Presence of at least one morphological evaluable lesion according to mRECIST 1.1 using contrast CT/MRI
- Patient must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
- Patient who are Child-Pugh A
- Patient must have a life expectancy 6 6 months as determined by the study investigator
- Patient affiliated to or beneficiary of the National Health Service
- Consent to practice double-barrier contraception after [68Ga]Ga-PSMA injection (6 months of contraception for women study participant and their partners, and 3 months for men study participant and their partners)
You will not qualify if you...
- Known hypersensitivity to PSMA-11, to any excipient or derivative or to radiographic contrast agents
- Patient requiring emergent surgery for a ruptured / bleeding HCC
- Radioembolization within 3 months prior to inclusion
- Cardiac disease with New York Heart Association classification of III or IV
- Any major surgery within 4 weeks before enrollment
- Other known malignancies (except for fully-resected non-melanoma skin cancer or cervical cancer in situ) unless definitively treated and proven no evidence of recurrence for 2 years
- Any uncontrolled significant medical, psychiatric or surgical condition (active infection (subjects with known human immunodeficiency virus (HIV) positive)), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus (glycated haemoglobin (HbA1c) 6 9%), uncontrolled congestive heart disease, etc.) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or that would limit compliance with the objectives and assessments of the study
- Woman who are pregnant or breastfeeding. A serum pregnancy test will be performed at the start of the study for all female subjects of childbearing potential
- Patient under guardianship or trusteeship
- Patient under judicial protection
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo dynamic whole-body [68Ga]Ga-PSMA PET/CT imaging to assess hepatocellular carcinoma.
1 visit (in-person)
Duration - 6 months
Participants are monitored for diagnostic performance outcomes over 6 months following imaging.
Follow-up visits as needed over 6 months
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
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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