$0.00
Shopping Cart
Facebook-f Instagram
Donate

Clinical Trial Record

Return to Clinical Trials

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

2025-03-01

2027-09-01

2027-09-01

60

Study Overview

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

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.

N/A

  • Hepatocellular Carcinoma (HCC)
  • Intrahepatic Cholangiocarcinoma (Icc)
  • Neuroendocrine Tumors
  • RADIATION: 89Zr-TLX250 PET/CT
  • RC23_0453

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-12-09  

N/A  

2024-12-13  

2024-12-13  

N/A  

2025-03-25  

2025-03-25  

N/A  

2024-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: 89Zr-TLX250

Patients will be injected with a single dose of 89Zr-TLX250.

RADIATION: 89Zr-TLX250 PET/CT

  • Patients will receive 89Zr-TLX250 for detection of CAIX-expressing tumor by PET imaging.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Tumor targeting of 89Zr-TLX250 PETNumber of tumor lesions detected by 89Zr-TLX250 PET in comparison with the lesions identified by morphological imaging at baseline.Day 5
Tumor targeting of 89Zr-TLX250 PETLocation of tumor lesions detected by 89Zr-TLX250 PET in comparison with the lesions identified by morphological imaging at baseline.Day 5
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Evaluation of tolerabilityUnexpected immediate adverse events up to post-administration of 89Zr-TLX250.Hour 2
Evaluation of tolerabilityNumber of participants with treatment-related adverse events as assessed by CTCAE v5.0Day 8
Diagnostic efficacySensitivity 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).Month 3
Diagnostic efficacyConcordance 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).Month 3
Assessment of tumor uptakeTumor quantitative measures on 89Zr-TLX250 PET.Day 8
Correlation with CAIXAssessment 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.Day 8
Assessment of the absorbed dosesQuantitative biodistribution of 89Zr-TLX250 will be evaluated from sequential whole body PET-CT imaging and pharmacokinetic data.Day 0
Assessment of the absorbed dosesQuantitative biodistribution of 89Zr-TLX250 will be evaluated from sequential whole body PET-CT imaging and pharmacokinetic data.Day 1
Assessment of the absorbed dosesQuantitative biodistribution of 89Zr-TLX250 will be evaluated from sequential whole body PET-CT imaging and pharmacokinetic data.Day 5
Assessment of the absorbed dosesQuantitative biodistribution of 89Zr-TLX250 will be evaluated from sequential whole body PET-CT imaging and pharmacokinetic data.Day 7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Clément BAILLY

Phone Number: +33240084136

Email: clement.bailly@chu-nantes.fr

Study Contact Backup

Name: Astrid GARREAU

Phone Number: +33253482840

Email: astrid.garreau@chu-nantes.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

    • 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Treat yourself

Let Us Take Care Of You

BOOK AN APPOINTMENT ⟶
footer logo

About

Events

Fundraising

Contact Us

Facebook-f Instagram

NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.

The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

Copyright © 2024 – National Pancreatic Cancer Foundation | All Rights Reserved

Make-A-Will Month

Snag 6508be92
Learn More
Donate Now Online
Other Ways to Donate