Bladder Cancer Clinical Trial
— PERTINENCEOfficial title:
A Pilot Open-label, Feasibility Study to Assess safEty, Tolerability, Radiation Dosimetry, and Imaging Properties of 89Zr-labeled giRenTuximab (89Zr-Girentuximab) in patIents With Non-musclE-iNvasive Bladder CancEr (NMIBC)
Verified date | January 2023 |
Source | Institut Cancerologie de l'Ouest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | September 26, 2022 |
Est. primary completion date | August 24, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Institut de cancerologie de l'Ouest | Saint Herblain |
Lead Sponsor | Collaborator |
---|---|
Institut Cancerologie de l'Ouest | ATONCO |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PET/CT imaging 89Zr-girentuximab biodistribution assessment | 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 | 3 days | |
Primary | 89Zr-girentuximab Blood dosing | 89Zr-girentuximab activity dosing in blood will be measured (Becquerel/ml : Bq/ml) at T0+20 hours | 2 days | |
Secondary | Assess the toxicity of 89Zr-girentuximab administered by intravesical instillation | 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 | 30 days | |
Secondary | Radiation protection management | Radiation exposure of staff (extremities, lens and Whole body: µSv) | 3 days | |
Secondary | Radiation protection management | Radiopharmaceutical management from intravesical instillation to elimination (surfasic contamination: counts/cm2 or Bq/cm2) | 1 day | |
Secondary | Assess the degree of CAIX expression by immunohistochemistry of the tumor | The expression of CAIX will be assessed by immunohistochemistry in tumor sample from TransUrethral Resection of Bladder Tumor (TURBT) or cystectomy | 3 months |
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