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

NCT06999837 | Recruiting

• 2 other identifiers: RC24_04822024-515178-28-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HCC - Hepatocellular Carcinoma

Keywords

68Ga-PSMA PET/CT; Hepatocellular carcinoma; multiparametric dynamic whole-body imaging

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance

  Sensitivity of qualitative assessment of dynamic whole-body \[68Ga\]Ga- PSMA PET/CT using standard imaging methods, pathological data if available data or imaging follow-up of at least 6 months as gold standard in two populations of HCC patients: at the time of initial diagnosis or upon detection of suspected refractory, residual, or recurrent relapse.

  6 months

Secondary Outcomes (6)

• Kinetic parameters

  Baseline

• Diagnostic performance of multiparametric image evaluation approach at the lesion level

  6 months

• Diagnostic performance of multiparametric image evaluation approach at the patient level

  6 months

• Diagnostic performance of multiparametric image evaluation approach at the patient level

  6 months

• Acceptability in terms of comfort

  Baseline

Study Arms (1)

[68Ga]Ga-PSMA

EXPERIMENTAL

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

Radiation: [68Ga]Ga-PSMA-11

Interventions

[68Ga]Ga-PSMA-11 RADIATION

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

[68Ga]Ga-PSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

HU Paris Nord APHP

Clichy, France

NOT YET RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Clément BAILLY

CONTACT

+33 2 40 08 41 36; clement.bailly@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 31, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): September 23, 2027
• Study Completion (Estimated): September 23, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

FR (2)