Exploring the Role of Carbonic Anhydrase IX as Diagnostic and Theranostic Target in Von-hippel Lindau Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- to assess the efficacy of CAIX-PET
研究概览
简要总结
The study is a phase 2, non-comparative and non-randomized, single arm, national clinical trial testing the hypothesis that CAIX-PET has diagnostic and theranostic potential in VHL disease and in VHL-/- tumors. Participants will receive a single dose of the diagnostic radiopharmaceutical [89Zr]Zr-DFO-Girentuximab and subsequently will be subjected to imaging with an hybrid PET/CT scanner. Sensitivity and diagnostic accuracy of experimental imaging will be assessed against standard of truth derived from standard of care procedures such as MRI or pathology following surgery. A theranostic approach will be simulated by replacing the physical decay of the diagnostic isotope [89Zr]Zr with the physical decay of therapeutic isotopes and evaluating tissue dosimetry.
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
- •Voluntarily given informed consent
- •Age ≥18 years old
- •Performance Status ECOG/WHO score 0-2
- •For females of reproductive potential, negative pregnancy test and use of highly effective contraception for 30 days following IMP administration
- •For males of reproductive potential, use of highly effective contraception for 30 days following IMP administration.
- •And, for the primary cohort:
- •Diagnosis of VHL disease requiring surveillance following confirmation of pathogenic variant at genetic test
- •Alternatively, for the secondary cohort:
- •- Clinical and/or pathological diagnosis of hemangioblastoma, pheochromocytoma, pancreatic neuroendocrine tumor or clear cell renal cell carcinoma requiring surgery.
排除标准
- •Performance Status ECOG/WHO score >2
- •Women who are pregnant or breastfeeding or are planning pregnancy during the study
- •Men who are planning fatherhood during the study
- •Exposure to any murine or chimeric antibodies within 5 years prior to the planned IMP administration
- •Exposure to any experimental diagnostic or therapeutic drug within 30 days from the planned IMP administration
- •Surgery, biopsy, ablative procedure, radiotherapy or any other local treatment for any primary tumor within 4 weeks prior to the planned IMP administration
- •Exposure to any systemic agent within 4 weeks prior to the planned IMP administration or in case of continuing adverse effects with grade >1 from such therapy
- •Current exposure to systemic agents or scheduled therapy in the next 6 months following the planned IMP administration
- •Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or within the safety of compliance of the subjects as judged by the Investigator
- •Known hypersensitivity to [89Zr]Zr-DFO-Girentuximab or DFO (Desferrioxamine)
- •Severe chronic kidney disease with glomerular filtration rate ≤ 30 mL/min/1.73m2
- •Other vulnerable categories than rare disease (e.g, being in detention)
研究组 & 干预措施
investigating the role of CAIX as target in VHL disease and in VHL-/- tumors
干预措施: investigating the role of CAIX as target in VHL disease and in VHL-/- tumors. (Drug)
结局指标
主要结局
to assess the efficacy of CAIX-PET
时间窗: IMP administration at day 0; CAIX-PET from day 3 to 7; MRI according to standard of care and imaging assessment from day 1 to 60.
to assess the Sensitivity of CAIX-PET for the diagnosis of tumors in VHL disease
次要结局
未报告次要终点
研究者
Larcher Alessandro
Medical Doctor
IRCCS Ospedale San Raffaele