A Pilot Study of 89Zr-girentuximab for PET Imaging in Residual or Recurrent Post Ablative Tumors in Patients With Renal Cell Carcinoma.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- SUVmean of the ablated zone and adjacent or contralateral uninvolved kidney
研究概览
简要总结
The goal of this clinical trial is to learn whether 89Zr-Girentuximab PET scans can inform management of renal cell carcinoma. The main questions it aims to answer are:
- Does the 89Zr-Girentuximab PET detect ccRCC that is left behind or has come back after treatment?
- What differences can be seen on the 89Zr-Girentuximab PET before and after standard of care treatment?
Participants in arm 1 will be given the study drug followed by a PET scan 3-7 days after injection. Participants in arm 2 will receive the same, but will proceed with their standard of care cryoablation after the initial PET scan. Within 3 days of the cryoablation treatment, participants will receive a repeat PET scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 and voluntarily given Informed Consent
- •≥18 years of age at time of consent
- •a. Because no dosing or adverse event data are currently available on the use of 89Zr-girentuximab in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- •Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
- •Findings suspicious for post-ablation residual or recurrent ccRCC (subjects in cohort 1) documented at conventional imaging or biopsy, performed within 90 days prior to 89Zr-girentuximab PET scan.
- •Findings suspicious for primary ccRCC (subjects in cohort 2) documented at standard histology or conventional imaging, performed within 90 days prior to 89Zr-girentuximab PET scan.
- •Negative serum or urine pregnancy tests in female patients of childbearing potential within 72 hours prior to receiving 89Zr-girentuximab. Female patients of non-child bearing potential must provide evidence by fulfilling one of the following criteria at screening:
- •Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
- •Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution
- •Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation
- •For all participants, consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-girentuximab administration.
排除标准
- •Renal mass known to be a metastasis of another primary tumor.
- •Active non-renal malignancy requiring therapy during and up to EOT visit.
- •Planned antineoplastic therapies (for the period between IV administration of 89Zr-girentuximab and imaging).
- •Previous administration of any radionuclide within 10 of its half-lives before 89Zr-girentuximab injection day.
- •Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic), that may interfere with the objectives of the program or with the safety or compliance of the subject, as judged by the Investigator.
- •Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the program.
- •Women who are pregnant or breastfeeding.
- •Known hypersensitivity to girentuximab or DFO (desferoxamine).
- •Renal insufficiency with estimated glomerular filtration rate eGFR ≤ 40 mL/min/ 1.73 m²
研究组 & 干预措施
Patients with ccRCC undergoing ablation
PET for evaluation of post-ablative kidney
干预措施: 89Zr-Girentuximab (Drug)
Patients with known or suspected recurrent or residual ccRCC
PET and Histological correlation
干预措施: 89Zr-Girentuximab (Drug)
结局指标
主要结局
SUVmean of the ablated zone and adjacent or contralateral uninvolved kidney
时间窗: From enrollment to 0-3 days after SOC cryoablation
Qualitative and quantitative assessment of 89Zr-girentuximab probe uptake of the ablative zone in the kidney will be performed. Guided by the findings of standard CT or MRI, a region of interest (ROI) will be drawn over the ablation zone and adjacent uninvolved kidney. SUVmean of the ROIs will be measured for the recurrent/residual tumor and the adjacent or contralateral normal kidney. Descriptive statistics including the mean SUVmean and standard deviation will be reported for each ROI. Tumor to kidney uptake ratio will also be calculated. It is expected that the recurrent/residual tumor will show uptake above the uninvolved kidney.
SUVmax of the ablated zone and adjacent or contralateral uninvolved kidney
时间窗: From enrollment to 0-3 days after SOC cryoablation
Qualitative and quantitative assessment of 89Zr-girentuximab probe uptake of the ablative zone in the kidney will be performed. Guided by the findings of standard CT or MRI, a region of interest (ROI) will be drawn over the ablation zone and adjacent uninvolved kidney. SUVmax of the ROIs will be measured for the recurrent/residual tumor and the adjacent or contralateral normal kidney. Descriptive statistics including the SUVmax and standard deviation will be reported for each ROI. Tumor to kidney uptake ratio will also be calculated. It is expected that the recurrent/residual tumor will show uptake above the uninvolved kidney.
次要结局
- Comparison of SUVmean on pre- and post-ablation scans(Baseline through 0-3 days days after SOC cryoablation)
- Comparison of SUVmax on pre- and post-ablation scans(Baseline through 0-3 days after SOC cryoablation)
研究者
Shadi Abdar Esfahani
Director of Nuclear Medicine Clinical Trials
Massachusetts General Hospital