HCC - Hepatocellular CarcinomaHIMIKONCT06999837
[68Ga]Ga-PSMA PET/CT in Hepatocellular Carcinoma: Impact of Multiparametric Dynamic Whole-body Imaging and Kinetic Modeling.
A study testing [68Ga]Ga-PSMA-11 in people with HCC - Hepatocellular Carcinoma, run by Nantes University Hospital at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- [68Ga]Ga-PSMA-11
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Sep 2025to 23 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
HU Paris Nord APHP
Clichy
Rachida LEBTAHI, rachida.lebtahi@aphp.fr
- Recruiting
CHU de Nantes
Nantes
Clément BAILLY, +33 2 40 08 41 36, clement.bailly@chu-nantes.fr
About this study
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
- Being tested
- [68Ga]Ga-PSMA-11
- Keywords
- 68Ga-PSMA PET/CT, Hepatocellular carcinoma, multiparametric dynamic whole-body imaging
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-PSMA-11Radiation
Dynamic whole-body [68Ga]Ga-PSMA acquisition to HCC patients
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-PSMA | Experimental | Dynamic whole-body [68Ga]Ga-PSMA acquisition to HCC patients Receives: Radiation: [68Ga]Ga-PSMA-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
Kinetic parameters
Patlak's parametric reconstruction, which estimates the 68 Gallium blood input function from the image, will be employed to extract the Ki absorption coefficient.
Measured: Baseline
Diagnostic performance of multiparametric image evaluation approach at the lesion level
Sensitivity value of D-WB [68Ga]Ga-PSMA PET/CT and gold standard will be calculated and compared at the lesion level.
Measured: 6 months
Diagnostic performance of multiparametric image evaluation approach at the patient level
Sensitivity value of static [68Ga]Ga-PSMA PET/CT and Choline-PET will be calculated and compared.
Measured: 6 months
Diagnostic performance of multiparametric image evaluation approach at the patient level
Sensitivity value of dynamic [68Ga]Ga-PSMA PET/CT and Choline-PET will be calculated and compared.
Measured: 6 months
Acceptability in terms of comfort
Acceptability will be measured by a comfort scale from 1 (very uncomfortable) to 5 (very comfortable).
Measured: Baseline
Dynamic compared to static imaging
Target-to-background ratios (TBR) values were compared with Tumor normalized uptake values (SUV images) to evaluate lesions detection.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start23 Sep 2025
- Primary completion23 Sep 2028 (estimated)
- Study completion23 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999837
- Sponsor's protocol ID
- RC24_0482
- Other IDs
- 2024-515178-28-00
- Acronym
- HIMIKO
- Status last verified
- Sep 2026
- First submitted
- 15 May 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [68Ga]Ga-PSMA PET/CT in Hepatocellular Carcinoma: Impact of Multiparametric Dynamic Whole-body Imaging and Kinetic Modeling.
- ClinicalTrials.gov ID
- NCT06999837
- Acronym / sponsor ID
- HIMIKO / RC24_0482
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- 68Ga-PSMA PET/CT, Hepatocellular carcinoma, multiparametric dynamic whole-body imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 23 Sep 2028 (estimated)
- Study completion
- 23 Sep 2028 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-PSMA | Experimental | Radiation: [68Ga]Ga-PSMA-11Dynamic whole-body [68Ga]Ga-PSMA acquisition to HCC patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-PSMA-11Dynamic whole-body [68Ga]Ga-PSMA acquisition to HCC patients | Radiation | [68Ga]Ga-PSMA |
Primary outcome
Diagnostic performance
Time frame: 6 months
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 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [68Ga]Ga-PSMA-11 in people with HCC - Hepatocellular Carcinoma, run by Nantes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clément BAILLY (+33 2 40 08 41 36, clement.bailly@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.