Multiparametric dynamic whole-body [68Ga]Ga-PSMA PET/CT for hepatocellular carcinoma
[68Ga]Ga-PSMA PET/CT in Hepatocellular Carcinoma: Impact of Multiparametric Dynamic Whole-body Imaging and Kinetic Modeling.
NA · Nantes University Hospital · NCT06999837
This will test whether multiparametric dynamic whole-body [68Ga]Ga-PSMA PET/CT can better detect and characterize hepatocellular carcinoma in adults who are newly diagnosed or who have suspected recurrent, residual, or refractory disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Locations | 2 sites (Clichy and 1 other locations) |
| Trial ID | NCT06999837 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) with histologically proven or radiologically diagnosed HCC who have at least one mRECIST-evaluable lesion, Child-Pugh A liver function, ECOG 0–2, expected survival ≥6 months, and who can comply with contraception and attend the participating sites.
Not a fit: Patients with decompensated liver disease (Child-Pugh B/C), ECOG >2, pregnant or breastfeeding individuals, those with known hypersensitivity to the tracer, or without an evaluable lesion are unlikely to benefit.
Why it matters
Potential benefit: If successful, this imaging approach could improve detection and characterization of HCC lesions and help guide biopsy and treatment decisions.
How similar studies have performed: PSMA PET/CT is well established in prostate cancer and early pilot reports show PSMA uptake can detect some HCC lesions, but multiparametric dynamic whole-body imaging with kinetic modeling is a relatively novel approach with limited prior data in HCC.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Clichy and 1 other locations
- HU Paris Nord APHP — Clichy, France (NOT_YET_RECRUITING)
- CHU de Nantes — Nantes, France (RECRUITING)
Study contacts
- Study coordinator: Clément BAILLY
- Email: clement.bailly@chu-nantes.fr
- Phone: +33 2 40 08 41 36
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HCC - Hepatocellular Carcinoma, 68Ga-PSMA PET/CT, Hepatocellular carcinoma, multiparametric dynamic whole-body imaging