Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, ICC or NEN

Not Applicable

Not yet recruiting

• Conditions: Hepatocellular Carcinoma (HCC); Intrahepatic Cholangiocarcinoma (Icc); Neuroendocrine Tumors

• Registration Number: NCT06735560
• Lead Sponsor: Nantes University Hospital

Brief 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. In this context, the tumor expression of carbonic anhydrase IX (CAIX), complemen...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Study Start: 2025-03-01
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Provided written informed consent.

2. Patients aged ≥ 18 years.

3. Histologically confirmed, unresectable locally advanced or metastatic solid tumors of:

   • HCC or ICC: expressing CAIX (less than 2 years), not eligible for local or loco- regional treatment, after failure of first line systemic therapy. In addition, for ICC, after targeted therapy in case of IDH1 mutation or FGFR fusion.
   • Progressive GEP-NENs (2019 WHO classification), functioning or non-function- ing, without or with low SSTR2 expression, after at least one line of standard therapy.

4. Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI.

5. Patients should not have received further antitumor therapy once disease progression is documented.

6. Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2.

7. For cirrhotic patients: Child-Pugh A.

8. Patient affiliated to or beneficiary of the National Health Service.

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Exclusion Criteria

1. Known hypersensitivity to zirconium-89, to any excipient or derivative or to radiographic contrast agents.
2. Chemotherapy, extensive external beam radiation, immunotherapy, targeted therapy, or angiogenesis inhibitors within 4 weeks prior to inclusion.
3. Radionucleide targeted therapy prior to inclusion within 6 months prior to inclusion.
4. Radioembolization within 3 months prior to inclusion.
5. Uncontrolled brain or spinal cord metastasis. Patients with a history of brain metastases must have a head CT or MRI with contrast to document stable brain disease 3 months prior to inclusion in the study.
6. Cardiac disease with New York Heart Association classification of III or IV.
7. Life expectancy shorter than 4 months.
8. Any major surgery within 4 weeks before enrollment.
9. 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.
10. 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.
11. 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 or refusing effective contraception method.
12. Patient under guardianship or trusteeship.
13. Patient under judicial protection.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tumor targeting of 89Zr-TLX250 PET	Day 5	Location of tumor lesions detected by 89Zr-TLX250 PET in comparison with the lesions identified by morphological imaging at baseline.

Secondary Outcome Measures

Name	Time	Method
Diagnostic efficacy	Month 3	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).
Assessment of tumor uptake	Day 8	Tumor quantitative measures on 89Zr-TLX250 PET.
Correlation with CAIX	Day 8	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.
Assessment of the absorbed doses	Day 7	Quantitative biodistribution of 89Zr-TLX250 will be evaluated from sequential whole body PET-CT imaging and pharmacokinetic data.
Evaluation of tolerability	Day 8	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Trial Locations

Locations (2)

CHU de Nantes; 🇫🇷 Nantes, France

AP-HP - Site de Beaujon; 🇫🇷 Paris, France