Imaging Performance Assessment of 89Zi-girentuximab (89Zr-TLX250) PET in Metastatic Triple Negative Breast Cancer (OPALESCENCE)

January 16, 2026 updated by: Institut Cancerologie de l'Ouest

Prospective Phase II Pilot Study, Assessing Imaging Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT (Positron Emission Tomography/Computerized Tomography) in Metastatic Triple Negative Breast Cancer Patients

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 metastatic triple negative breast cancer (TNBC) patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 metastatic triple negative breast cancer (TNBC) patients.

TNBC patients are known to be rapidly progressive and have a poor prognosis. This poor prognosis is due to the lack of common breast cancer targets in TNBC. As TNBC expresses CAIX, this stuy will evaluate CAIX targeting by using a radiolabeled monoclonal antibody that recognizes carbonic anhydrase IX (CAIX) : 89Zr- girentuximab otherwise known as 89Zr-TLX250. Previous and ongoing studies have demonstrated the potential application of 89Zr-TLX250 as a new PET/CT imaging tracer for the detection of renal cancer.

After establishing the TNBC targeting properties of the 89Zr-TLX250 PET/CT imaging tracer, it should be interesting to develop a new targeted therapy using TLX250- radiolabeled with a therapeutic radionuclide such as 177Lutétium.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • France
      • Saint-Herblain, France, 44805
        • Ico Rene Gauducheau

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
  • Female or male, Age ≥ 18 years at time of study entry.

  • Primitive triple negative breast cancer proven histologically, defined according to the following criteria:

    • Estrogen receptors <10%.
    • And progesterone receptors <10%.
    • And Human Epidermal Growth factor Receptor 2 (HER2) not amplified or not overexpressed.
  • Breast Cancer (BC) recurrence documented by conventional imaging and/or FDG PET/CT with at least one measurable metastatic lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) and/or PET Response Criteria In Solid Tumors (PERCIST).
  • Consent to use a contraception method for at least 30 days after administration of 89Zr-TLX250.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  • Life expectancy at least 6 months.
  • Patient has valid health insurance.
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Exclusion Criteria:

  • History of another primary malignancy except for basal cell carcinoma within the last 5 years.
  • Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
  • Planned antineoplastic therapies (for the period between IV administration of 89Zr-TLX250 and imaging).
  • Exposure to murine or chimeric antibodies within the last 5 years.
  • Previous administration of any radionuclide within 10 half-lives of the same.
  • Impossibility to hold lying motionless at least 1 hour, or known claustrophobia.
  • Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator.
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  • Pregnant or likely to be pregnant or nursing patient.
  • Known hypersensitivity to girentuximab or desferoxamine.
  • Renal insufficiency with Glomerular Filtration Rate : GFR ≤ 45 mL/min/ 1.73 m².
  • Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.
  • Disorder precluding understanding of trial information or informed consent.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 89Zr-TLX250 PET/CT
Drug: 89Zr-TLX250
89Zr-TLX250 PET/CT
Other Names:
  • 89Zr-girentuximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT
Time Frame: 5 days
The number of total lesions detected on 89Zr-TLX250 PET/CT versus 18FDG PET/CT is reported to assess the concordance for tumor lesion detection using 89Zr-TLX250 PET/CT and 18FDG) PET/CT
5 days
Number of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Time Frame: 5 days
Number of breast lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
5 days
Number of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Time Frame: 5 days
Number of bone lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
5 days
Number of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Time Frame: 5 days
Number of lymph nodes lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
5 days
Number of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Time Frame: 5 days
Number of lung lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
5 days
Number of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Time Frame: 5 days
Number of liver lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and on 18FDG PET/CT
5 days
Number of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT
Time Frame: 5 days

Number of brain lesions seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT will be reported in order to evaluate the sensitivity of 89Zr-TLX250 PET/CT and 18FDG PET/CT.

The detection performance of 89Zr-TLX250 PET/CT and 18FDG PET/CT for identifying brain lesions has been compared.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT
Time Frame: 5 days
Total tumor burden (whole body) detected on 89Zr-TLX250 PET/CT scan compared to that defined on 18FDG PET/CT used as the reference performed at day 3 (D3) and at day 5 (D5)
5 days
Number of Patient With Concordance Between the 89Zr-TLX250 PET/CT Uptake and CAIX Histological Expression
Time Frame: 5 days
Number of patients with a concordance between the 89Zr-TLX250 PET/CT uptake and CAIX histological expression considered as positive or negative
5 days
Number of Participants With Adverse Events Related to 89Zr-TLX250
Time Frame: 30 days
All Adverse Events related to 89Zr-TLX250 are reported and assessed using CTCAE v5.0 scale
30 days
Number of Participants With Serious Adverse Events Related or Not to 89Zr-TLX250
Time Frame: 30 days
All Serious Adverse Events are collected between the 89Zr-TLX250 administration and 30 days after. They assessed using CTCAE v5.0 scale
30 days

Collaborators and Investigators

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

Sponsor

Institut Cancerologie de l'Ouest

Collaborators

Telix Pharmaceutical
SIRIC ILIAD

Investigators

  • Study Chair: Caroline ROUSSEAU, MD, Institut de Cancerologie de l'Ousest - ICO

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Actual)

September 21, 2021

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

September 13, 2023

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-2020-25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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