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)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants With Uptake Spot in 89Zr-girentuximab PET/CT Images
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
89Zr-TLX250
89Zr-TLX250 (89Zr-girentuximab) PET/CT performed for all aptients
干预措施: 89Zr-TLX250 (Drug)
结局指标
主要结局
Number of Participants With Uptake Spot in 89Zr-girentuximab PET/CT Images
时间窗: 3 days
The presence or absence of uptake spot in bladder wall of 89Zr-girentuximab bladder and whole body PET/CT Images.
Number of Patients With Positive and Negative 89Zr-girentuximab Blood Dosing
时间窗: 2 days
89Zr-girentuximab activity dosing in blood is measured. The number of patients with Positive and negative 89Zr-girentuximab Blood dosing is evaluated.
次要结局
- Number of Participants With Serious Adverse Events(30 days)
- Number of Patients With Positive and Negative CA-IX Expression in Tumor Cells(3 months)
- Number of Participants With Adverse Events Related to 89Zr-girentuximab(3 days)
- Radiation Protection Management(1 day)
- Radiation Protection Management(3 days)