Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, BTC or NEN
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 89Zr-TLX250 PET/CT.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc), Neuroendocrine Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Radiation 89Zr-TLX250 PET/CT
Patients will receive 89Zr-TLX250 for detection of CAIX-expressing tumor by PET imaging.
Primary outcome measures
- Tumor targeting of 89Zr-TLX250 PET [Time frame: Day 5]
- Tumor targeting of 89Zr-TLX250 PET [Time frame: Day 5]
Secondary outcome measures (10)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 2 centers
- CHU de Nantes — Nantes
- AP-HP - Site de Beaujon — Paris
Identifiers
NCT: NCT06735560 · RC23_0453