Multiparametric dynamic whole-body [68Ga]Ga-PSMA PET/CT for hepatocellular carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses multiparametric dynamic whole-body [68Ga]Ga-PSMA PET/CT with kinetic modeling to quantify tracer behavior in patients with hepatocellular carcinoma. Participants are enrolled into two cohorts: newly diagnosed patients scheduled for biopsy and patients undergoing new imaging for suspected refractory, residual, or recurrent disease. Imaging findings will be compared with standard contrast-enhanced CT or MRI and correlated with histology when available. Safety monitoring follows standard radiotracer precautions and contraception requirements are mandated after injection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provided written informed consent
2. Patient aged ≥ 18 years
3. 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
4. Presence of at least one morphological evaluable lesion according to mRECIST 1.1 using contrast CT/MRI
5. Patient must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2
6. Patient who are Child-Pugh A
7. Patient must have a life expectancy ≥ 6 months as determined by the study investigator
8. Patient affiliated to or beneficiary of the National Health Service
9. 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)

Exclusion Criteria:

1. Known hypersensitivity to PSMA-11, to any excipient or derivative or to radiographic contrast agents
2. Patient requiring emergent surgery for a ruptured / bleeding HCC
3. Radioembolization within 3 months prior to inclusion
4. Cardiac disease with New York Heart Association classification of III or IV
5. Any major surgery within 4 weeks before enrollment
6. 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
7. 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
8. 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
9. Patient under guardianship or trusteeship
10. Patient under judicial protection

Where it's running

• CHU de Nantes
  Nantes, France Recruiting
• HU Paris Nord APHP
  Clichy, France Not yet recruiting

Study contacts

• Study coordinator: Clément BAILLY
• Email: clement.bailly@chu-nantes.fr
• Phone: +33 2 40 08 41 36

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.