ISRCTN46904744进行中（未招募）1 期
A phase 1, prospective study to compare safety, tolerability, biodistribution and pharmacokinetics of a single dose of 89Zr-DFO- girentuximab with the antibody produced by ADRM-free adapted cell lines or original cell lines in patients with indeterminate renal masses
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients =18 years of age at time of informed consent signature
- •2. Have morphological imaging evidence of a single renal mass of =7 cm in largest diameter on standard of care (SoC) imaging (CT/MRI) based on national standards, requiring further diagnostic work-up a. Patients with a history of ccRCC and renal lesion of unclear origin during follow-up may also be included
- •3. Life expectancy of at least 6 months
- •4. Availability of a pre-study morphological image (contrast-enhanced CT or MRI scan) showing a renal mass within 90 days prior to dosing with 89Zr-DFO-girentuximab.
- •5. Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
- •6. Negative serum pregnancy tests in female patients of child-bearing potential at screening. Confirmation of negative pregnancy test results from urine within 24 hours prior to receiving investigational product.
- •7. Participants must agree to practice adequate precautions to prevent pregnancy, including male patients with female of child-bearing potential partners and to avoid potential problems associated with radiation exposure to the unborn child (Refer to 10.2, Appendix 2).
- •8. Participants must comply with the radiation protection rules that are used by the treating institution in order to protect their close contacts and the general public.
- •9. Participant agrees not to participate in another interventional study while participating in the present study.
排除标准
- •1. Other radiopharmaceutical administered within ten physical half-lives (of the radionuclide) of intended administration of 89Zr-DFO-girentuximab (i.e., within ten physical half-lives of Day 0)
- •2. Exposure to any experimental diagnostic or therapeutic agent within 30 days of planned administration of 89Zr-DFO-girentuximab (i.e., within 30 days of day 0).
- •3. Known uncontrolled hyperthyroidism.
- •4. Any planned antineoplastic therapies to be administered between administration of 89Zr-DFO-girentuximab and imaging.
- •5. Established diagnosis of renal cell carcinoma in the renal mass
- •6. Any clinically significant abnormalities detected during screening blood tests or physical exam that in the opinion of the investigator would adversely affect the participants’ ability to participate in the study.
- •7. Known allergy, hypersensitivity, or intolerance to girentuximab or any of the components of the investigational agent.
- •8. Psychiatric, cognitive, or other condition that, in the opinion of the investigator, compromises full compliance with the requirements of the study.
- •9. Women who are pregnant or breast-feeding
- •10. Exposure to murine or chimeric antibodies within the last 5 years
- •11. Serious but non life-threatening diseases or any other health conditions which the investigator determines may impact patient safety, compliance, and the integrity of the study data.
- •12. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr-DFO-girentuximab or continuing adverse effects (> Grade 1) from such therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
- •13. Planned antineoplastic therapies (for the period between IV administration of
- •89Zr-DFO-girentuximab and imaging)
- •14. Known hypersensitivity to girentuximab or DFO.
- •15. Renal insufficiency with GFR = 45 mL/min/ 1.73 m²
研究者
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