Hepatocellular Carcinoma (HCC)ELEGANCENCT06735560
Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, BTC or NEN
A study testing 89Zr-TLX250 PET/CT in people with Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (Icc), run by Nantes University Hospital at 2 sites in France.
Trial summary
Precision medicine represents a major goal in oncology. It has its underpinning in the identification of biomarkers with diagnostic, prognostic, or predictive values. Gastro-entero-pancreatic neuroendocrine neoplasia (GEP-NENs) are rare tumors, but their frequency is increasing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc), Neuroendocrine Tumors
- What is being tested?
- 89Zr-TLX250 PET/CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Nov 2025to 4 Aug 2027
- 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.
- Patients aged ≥ 18 years.
- - For basket 1 and 2: HCC or ICC histologically proven: newly diagnosed patients or patients with suspected refractory, residual, or recurrent disease.
- For basket 3: Progressive GEP-NENs with low or heterogeneous expression of SSTR2 or progressive pancreatic NENs which previously received at least two systemic treatments (excluding SSA) or pancreatic NENs with germline or somatic VHL mutation or G3 GEP-NENs .
- Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI.
- Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2.
- For cirrhotic patients: Child-Pugh ≤ B7.
- Patient affiliated to or beneficiary of the National Health Service.
Who cannot join
- Known hypersensitivity to zirconium-89, to any excipient or derivative or to radiographic contrast agents.
- Chemotherapy, extensive external beam radiation, immunotherapy, targeted therapy, or angiogenesis inhibitors within 2 weeks prior to 89Zr-TLX250 administration.
- Radionucleide targeted therapy prior to inclusion within 3 months prior to inclusion.
- Radioembolization within 3 months prior to inclusion.
- Uncontrolled brain or spinal cord metastasis.
- Cardiac disease with New York Heart Association classification of III or IV.
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- Life expectancy shorter than 4 months.
- Any major surgery within 4 weeks before enrollment.
- 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.
- 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.
- Women 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
- Recruiting
CHU de Nantes
Nantes
Clément BAILLY, +33240084136, clement.bailly@chu-nantes.fr
Yann TOUCHEFEU, +33240083152, yann.touchefeu@chu-nantes.fr
- Not yet recruiting
AP-HP - Site de Beaujon
Paris
Rachida LEBTAHI, +33140875169, rachida.lebtahi@aphp.fr
Mohamed BOUATTOUR, +33140875614, mohamed.bouattour@aphp.fr
About this study
Official title: Prospective Pilot Study Assessing Imaging Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in Patients With HepatoCellular Carcinoma, Biliary Tract Carcers or Gastro-Entero-Pancreatic Neuroendocrine Neoplasms.
Precision medicine represents a major goal in oncology. It has its underpinning in the identification of biomarkers with diagnostic, prognostic, or predictive values. Gastro-entero-pancreatic neuroendocrine neoplasia (GEP-NENs) are rare tumors, but their frequency is increasing. In this context, the tumor expression of carbonic anhydrase IX (CAIX), complemented by a restricted profile in normal tissues, provides an opportunity for therapeutic targeting and precision medicine. Indeed, radiolabeling the anti-CAIX monoclonal antibody girentuximab with Zirconium 89 has shown promise as a novel positron emission tomography (PET) tracer and labeling with 177 Lutetium promise as a therapeutic agent in clear cell renal cell carcinoma (ccRCC) in the context of a theranostic approach. The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT tracer for the imaging of Gastro-Entero-Pancreatic Neuroendocrine Neoplasms, Hepatocellular Carcinoma or IntraHepatic Cholangiocarcinoma.
- Conditions
- Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc), Neuroendocrine Tumors
- Being tested
- 89Zr-TLX250 PET/CT
- Keywords
- immunoPET, CAIX, GEP-NEN, ICC, HCC
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-TLX250 PET/CTRadiation
Patients will receive 89Zr-TLX250 for detection of CAIX-expressing tumor by PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-TLX250 | Experimental | Patients will be injected with a single dose of 89Zr-TLX250. Receives: Radiation: 89Zr-TLX250 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor targeting of 89Zr-TLX250 PET
Number of tumor lesions detected by 89Zr-TLX250 PET in comparison with the lesions identified by morphological imaging at baseline.
Measured: Day 5
Tumor targeting of 89Zr-TLX250 PET
Location of tumor lesions detected by 89Zr-TLX250 PET in comparison with the lesions identified by morphological imaging at baseline.
Measured: Day 5
Secondary outcomes (10)
Evaluation of tolerability
Unexpected immediate adverse events up to post-administration of 89Zr-TLX250.
Measured: Hour 2
Evaluation of tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Day 8
Diagnostic efficacy
Sensitivity of 89Zr-TLX250 PET/CT in the detection of tumor lesions as compared to a composite truth standard (determined on the basis of histology and conventional morphological or PET imaging).
Measured: Month 3
Diagnostic efficacy
Concordance of 89Zr-TLX250 PET/CT in the detection of tumor lesions as compared to a composite truth standard (determined on the basis of histology and conventional morphological or PET imaging).
Measured: Month 3
Assessment of tumor uptake
Tumor quantitative measures on 89Zr-TLX250 PET.
Measured: Day 8
Correlation with CAIX
Assessment of the correlation between the normalized uptake values (SUVmax) of 89Zr-TLX250 positive lesions and CAIX histological expression will be done by comparing the 89Zr-TLX250 semi-quantitative data with the immunohistochemical results (IHC) of biopsied lesions.
Measured: Day 8
Assessment of the absorbed doses
Quantitative biodistribution of 89Zr-TLX250 will be evaluated from sequential whole body PET-CT imaging and pharmacokinetic data.
Measured: Day 0
Assessment of the absorbed doses
Quantitative biodistribution of 89Zr-TLX250 will be evaluated from sequential whole body PET-CT imaging and pharmacokinetic data.
Measured: Day 1
Assessment of the absorbed doses
Quantitative biodistribution of 89Zr-TLX250 will be evaluated from sequential whole body PET-CT imaging and pharmacokinetic data.
Measured: Day 5
Assessment of the absorbed doses
Quantitative biodistribution of 89Zr-TLX250 will be evaluated from sequential whole body PET-CT imaging and pharmacokinetic data.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start4 Nov 2025
- Primary completion4 May 2027 (estimated)
- Study completion4 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- 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
- 60 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
- NCT06735560
- Sponsor's protocol ID
- RC23_0453
- Acronym
- ELEGANCE
- Status last verified
- May 2026
- First submitted
- 9 Dec 2024
- Last updated
- 13 May 2026
- Results posted
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study Assessing Imaging Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in Patients With HepatoCellular Carcinoma, Biliary Tract Carcers or Gastro-Entero-Pancreatic Neuroendocrine Neoplasms.
- ClinicalTrials.gov ID
- NCT06735560
- Acronym / sponsor ID
- ELEGANCE / RC23_0453
- Conditions
- Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc), Neuroendocrine Tumors
- Keywords
- immunoPET, CAIX, GEP-NEN, ICC, HCC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 4 May 2027 (estimated)
- Study completion
- 4 Aug 2027 (estimated)
- First posted
- 16 Dec 2024 (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.
Precision medicine represents a major goal in oncology. It has its underpinning in the identification of biomarkers with diagnostic, prognostic, or predictive values. Gastro-entero-pancreatic neuroendocrine neoplasia (GEP-NENs) are rare tumors, but their frequency is increasing. In this context, the tumor expression of carbonic anhydrase IX (CAIX), complemented by a restricted profile in normal tissues, provides an opportunity for therapeutic targeting and precision medicine. Indeed, radiolabeling the anti-CAIX monoclonal antibody girentuximab with Zirconium 89 has shown promise as a novel positron emission tomography (PET) tracer and labeling with 177 Lutetium promise as a therapeutic agent in clear cell renal cell carcinoma (ccRCC) in the context of a theranostic approach. The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT tracer for the imaging of Gastro-Entero-Pancreatic Neuroendocrine Neoplasms, Hepatocellular Carcinoma or IntraHepatic Cholangiocarcinoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-TLX250 | Experimental | Radiation: 89Zr-TLX250 PET/CTPatients will be injected with a single dose of 89Zr-TLX250. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provided written informed consent.
- Patients aged ≥ 18 years.
- - For basket 1 and 2: HCC or ICC histologically proven: newly diagnosed patients or patients with suspected refractory, residual, or recurrent disease.
- Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI.
- Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2.
Key exclusion criteria (13 listed)
- Known hypersensitivity to zirconium-89, to any excipient or derivative or to radiographic contrast agents.
- Chemotherapy, extensive external beam radiation, immunotherapy, targeted therapy, or angiogenesis inhibitors within 2 weeks prior to 89Zr-TLX250 administration.
- Radionucleide targeted therapy prior to inclusion within 3 months prior to inclusion.
- Radioembolization within 3 months prior to inclusion.
- Uncontrolled brain or spinal cord metastasis.
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 |
|---|---|---|
| 89Zr-TLX250 PET/CTPatients will receive 89Zr-TLX250 for detection of CAIX-expressing tumor by PET imaging. | Radiation | 89Zr-TLX250 |
Primary outcome
Tumor targeting of 89Zr-TLX250 PET
Time frame: Day 5
Number of tumor lesions detected by 89Zr-TLX250 PET in comparison with the lesions identified by morphological imaging at baseline.
Tumor targeting of 89Zr-TLX250 PET
Time frame: Day 5
Location of tumor lesions detected by 89Zr-TLX250 PET in comparison with the lesions identified by morphological imaging at baseline.
10 secondary outcomes
Evaluation of tolerability
Time frame: Hour 2
Evaluation of tolerability
Time frame: Day 8
Diagnostic efficacy
Time frame: Month 3
Diagnostic efficacy
Time frame: Month 3
Assessment of tumor uptake
Time frame: Day 8
Correlation with CAIX
Time frame: Day 8
Assessment of the absorbed doses
Time frame: Day 0
Assessment of the absorbed doses
Time frame: Day 1
Assessment of the absorbed doses
Time frame: Day 5
Assessment of the absorbed doses
Time frame: Day 7
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 13 May 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 89Zr-TLX250 PET/CT in people with Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (Icc), 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 8 inclusion and 13 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 13 May 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 (+33240084136, 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?
Tumor targeting of 89Zr-TLX250 PET (time frame: Day 5). The study lists 2 primary outcomes in all. 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 13 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.