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

NCT ID: NCT06999837

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-23

Study Completion Date

2027-09-23

Brief Summary

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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.

Detailed Description

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Conditions

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HCC - Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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[68Ga]Ga-PSMA

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

Group Type EXPERIMENTAL

[68Ga]Ga-PSMA-11

Intervention Type RADIATION

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

Interventions

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[68Ga]Ga-PSMA-11

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HU Paris Nord APHP

Clichy, , France

Site Status NOT_YET_RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Clément BAILLY

Role: CONTACT

+33 2 40 08 41 36

Facility Contacts

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Rachida LEBTAHI

Role: primary

Clément BAILLY

Role: primary

+33 2 40 08 41 36

Other Identifiers

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2024-515178-28-00

Identifier Type: CTIS

Identifier Source: secondary_id

RC24_0482

Identifier Type: -

Identifier Source: org_study_id

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