Phase 2
Completed N=12
Imaging Performance Assessment of 89Zi-girentuximab (89Zr-TLX250) PET in Metastatic Triple Negative Breast Cancer
Triple Negative Breast Cancer
Source: ClinicalTrials.gov NCT04758780 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT — 264; 231 lesions
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Total Lesions Detected on 89Zr-TLX250 PET/CT Versus 18FDG PET/CT |
264; 231 | — |
| PRIMARY Number of Brain Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT |
3; 1 | — |
| PRIMARY Number of Breast Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT |
25; 23 | — |
| PRIMARY Number of Bone Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT |
102; 111 | — |
| PRIMARY Number of Lymph Nodes Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT |
65; 74 | — |
| PRIMARY Number of Lung Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT |
17; 27 | — |
| PRIMARY Number of Liver Lesions Seen on 89Zr-TLX250 PET/CT and on 18FDG PET/CT |
12; 19 | — |
| SECONDARY Tumor Burden Volume by 18FDG PET/CT and 89Zr-TLX250 PET/CT |
41.01; 37.42; 41.21; 51.79 | — |
| SECONDARY Number of Patient With Concordance Between the 89Zr-TLX250 PET/CT Uptake and CAIX Histological Expression |
7; 5 | — |
| SECONDARY Number of Participants With Adverse Events Related to 89Zr-TLX250 |
— | — |
| SECONDARY Number of Participants With Serious Adverse Events Related or Not to 89Zr-TLX250 |
— | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT04758780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.