Assessment of Safety, Tolerability, Radiation Dosimetry, Imaging Properties of 89Zr-girentuximab in Patients With NMIBC

Inclusion Criteria:

* Written informed consent obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
* Female or male, Age ≥ 18 years at time of study entry.
* Performance Status: 0 or 1.
* Clinical evidence of NMIBC based on cystoscopy and proven histologically of papillary tumors.
* Histologically-confirmed pTa Grade 3 or pT1 Grade 3 bladder cancer patients relapsing without muscle invasion.
* Negative sterile Urine cytobacteriological testing at baseline (T0).
* Consent to use a contraception method for at least 30 days after administration of 89Zr-girentuximab.
* Patient has valid health insurance.

Exclusion Criteria:

* Patient with urinary incontinence.
* Known hypersensitivity to girentuximab.
* Exposure to any experimental diagnostic or therapeutic drug within 30 days prior the date of planned administration of 89Zr-girentuximab
* Exposure to any radiopharmaceutical within 30 days (corresponding to 10 half-lives of Zr-89) prior to the administration of 89Zr-girentuximab
* Patients suffering from a bladder cancer at stage pT2, pT3 or pT4
* Serious non-malignant disease that may interfere with the objectives of the study or with the safety or compliance of the patient; as judged by the investigator
* Concomitant cancer in the past 5 years except cutaneous cancers (except melanoma) and in situ carcinoma
* Prior chemotherapy, radiotherapy (other than short cycle of palliative radiotherapy), immunotherapy within 21 days of 89Zr-girentuximab administration
* Patients with known human immunodeficiency viruses (HIV), Hepatitis B virus (HBV) and Hepatitis C Virus (HCV) infections,
* Pregnant or likely to be pregnant or nursing patient.
* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
* Persons deprived of their liberty, under a measure of safeguard of justice, under guardianship or placed under the authority of a guardian.