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

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.