[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
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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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-09-23
2027-09-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[68Ga]Ga-PSMA
Dynamic whole-body \[68Ga\]Ga-PSMA acquisition to HCC patients
[68Ga]Ga-PSMA-11
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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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HU Paris Nord APHP
Clichy, , France
CHU de Nantes
Nantes, , France
Countries
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Central Contacts
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Facility Contacts
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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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