Assessment of safEty, Tolerability, Radiation Dosimetry, and Imaging Properties of 89Zr-labeled giRenTuximab (89Zr-Girentuximab) in patIents With Non-musclE-iNvasive Bladder CancEr (NMIBC)
- Conditions
- Bladder Cancer
- Interventions
- Drug: 89Zr-TLX250 PET/CT
- Registration Number
- NCT04897763
- Lead Sponsor
- Institut Cancerologie de l'Ouest
- Brief 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 radiopharmaceutical for the imaging of Non-muscle-invasive bladder cancer (NMIBC) patients.
- Detailed Description
There is a real need for treatment of NMIBC. Currently, treatment options include Bacillus Calmette-Guerin (BCG) intravesical immunotherapy and mitomycin C chemotherapy. These therapies are efficient for some time but relapses repeat them at more and more close intervals and finally patients are refractory to them and require a radical cystectomy.
CAIX is expressed in 70% to 90% of bladder cancers but not in normal urothelial tissue. CAIX is expressed on the membrane of Non-Muscle-Invasive Bladder Cancer cells.
Girentuximab, an anti-CAIX antibody could be a promising target in NMIBC. PET/CT with Girentuximab labelled with 89Zirconium will be used for diagnosis purpose. 89Zr-Girentuximab will be administered by intravesical instillation.
In this study, patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) will be enrolled in this study after confirmation of their eligibility.
A single intravesical administration of 89Zr-Girentuximab will be performed at day 0.
Multiple PET/CT imaging sessions will be performed on day 0, day 1 and day 2 in order to evaluate the bladder and the whole body 89Zr girentuximab uptake.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 89Zr-TLX250 PET/CT 89Zr-TLX250 PET/CT Pretherapeutic 89Zr-TLX250 PET/CT
- Primary Outcome Measures
Name Time Method PET/CT imaging 89Zr-girentuximab biodistribution assessment 3 days Standardized Uptake Values (SUVs) of bladder and whole body uptake will be evaluated by PET/CT imaging at T0, T0+2 hours, T0+20 hours and T0+44 hours
89Zr-girentuximab Blood dosing 2 days 89Zr-girentuximab activity dosing in blood will be measured (Becquerel/ml : Bq/ml) at T0+20 hours
- Secondary Outcome Measures
Name Time Method Radiation protection management 1 day Radiopharmaceutical management from intravesical instillation to elimination (surfasic contamination: counts/cm2 or Bq/cm2)
Assess the toxicity of 89Zr-girentuximab administered by intravesical instillation 30 days Number of adverse events due to intravesical administration of 89Zr-Girentuximab up to Day 30 after 89Zr-girentuximab administration. Adverse events will be assessed by using CTC-AE scale version 5.0
Assess the degree of CAIX expression by immunohistochemistry of the tumor 3 months The expression of CAIX will be assessed by immunohistochemistry in tumor sample from TransUrethral Resection of Bladder Tumor (TURBT) or cystectomy
Trial Locations
- Locations (1)
Institut de cancerologie de l'Ouest
🇫🇷Saint Herblain, France