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

Overview

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.

Interventions

• Radiation [68Ga]Ga-PSMA-11
  Dynamic whole-body \[68Ga\]Ga-PSMA acquisition to HCC patients

Primary outcome measures

• Diagnostic performance [Time frame: 6 months]

Secondary outcome measures (6)

• Kinetic parameters [Time frame: Baseline]
• Diagnostic performance of multiparametric image evaluation approach at the lesion level [Time frame: 6 months]
• Diagnostic performance of multiparametric image evaluation approach at the patient level [Time frame: 6 months]
• Diagnostic performance of multiparametric image evaluation approach at the patient level [Time frame: 6 months]
• Acceptability in terms of comfort [Time frame: Baseline]
• Dynamic compared to static imaging [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 2 centers

• HU Paris Nord APHP — Clichy
• CHU de Nantes — Nantes

Identifiers

NCT: NCT06999837 · RC24_0482 · 2024-515178-28-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗