[68Ga]Ga-PSMA PET/CT in Hepatocellular Carcinoma: Impact of Multiparametric Dynamic Whole-body Imaging and Kinetic Modeling.

Recruiting now · Not applicable

Conditions studied: HCC - Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID: NCT06999837
Run by: Nantes University Hospital
People needed: 40
Starts: 2025-09-23
Expected to finish: 2027-09-23
Last updated by the study team: 2025-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Provided written informed consent
Patient aged ≥ 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 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 may not qualify if…

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) ≥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

Where it is running

CHU de Nantes — Nantes, France (enrolling)
HU Paris Nord APHP — Clichy, France

Full record on ClinicalTrials.gov

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