A Single-centre, Open-label, Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Comparison of the sensitivity and specificity of 89Zr-girentuximab PET with FDG PET
研究概览
简要总结
The aim of this study is to determine if it is practical to use 89Zr-TLX250 PET/CT in the staging and detection of localized and metastatic urothelial carcinoma or bladder cancer.
The primary objective is to evaluate the feasibility of using 89Zr-TLX250 PET/CTas a new diagnostic and staging modality to detect urothelial carcinoma or bladder cancer.
详细描述
This will be a non-randomised, non-blinded, single centre, phase 1 feasibility study comparing 89Zr-girentuximab PET with FDG PET in patients with urothelial carcinoma or bladder cancer. This study would include 2 cohorts of adult patients; those with known metastatic urothelial carcinoma and bladder cancer and those undergoing primary staging for recently diagnosed urothelial carcinoma or bladder cancer.
This study is open-label, single centre and eligible patients will receive a single administration of study drug prior to imaging on day 5 (+/- 2 days). PET scans will be independently interpreted by nuclear medicine physicians blinded to the FDG PET findings. For patients proceeding to radical cystectomy, subsequent histological confirmation of areas of increased uptake will be retrospectively correlated with both PET scans.
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
- 是
入选标准
- •Patients aged 18 or older with bladder cancer or urothelial carcinoma who are able to provide informed consent
- •Negative serum pregnancy test in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
- •Consent to practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration.
排除标准
- •Active malignancy other than urothelial carcinoma or bladder cancer
- •Administration of a radioisotope within 10 physical half-lives prior to study enrolment.
- •Administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89Zr-TLX250 or continuing adverse effects from such therapy
- •Planned antineoplastic therapies for the period between administration of 89Zr-TLX250 and imaging
- •Serious non-malignant disease that may interfere with the objectives of the study
- •Renal insufficiency with glomerular filtration rate ≤45 mL/min/1.73m2
- •Pregnancy or lactation
- •Exposure to murine or chimeric antibodies within the last 5 years
- •Known hypersensitivity or human anti-chimeric antibodies against girentuximab
- •Exposure to any experimental diagnostic or therapeutic drug 30 days prior to the date of planned administration of 89Zr-TLX250
- •Contraindications to FDG PET/CT
研究组 & 干预措施
Administration of 89Zr-Girentuximab
Administration of 89Zr-Girentuximab as per protocol
干预措施: 89Zr-Girentuximab (Drug)
结局指标
主要结局
Comparison of the sensitivity and specificity of 89Zr-girentuximab PET with FDG PET
时间窗: Day 1 - Day 90
Sensitivity and specificity will be established following histological confirmation
次要结局
- Number of participants with treatment related adverse events related to 89Zr-girentuximab administration(Day 1 to Day 90)
- To evaluate the correlation between 89Zr-girentuximab SUV's and degree of urinary carbonic anhydrase IX excretion (cytology and CA-IX via PCR).(Day 1)
- To quantify the correlation between tumour volume using MIM quantitative software and histopathological findings(Day 1 - Day 90)