INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of iodinated contrast enhancement within the metastasis on post-injection CT
研究概览
简要总结
The purpose of this study is to plan for future clinical trials in patients with metastatic urological cancers. Diluted iodinated contrast will be injected intra-tumorally under CT fluoroscopy guidance into bone, lymph node, soft tissue and liver metastases in subjects with metastatic prostate cancer, urothelial carcinoma, or renal cell carcinoma. Pre- and post-injection CT images will be obtained to determine the injection parameters needed for optimal distribution throughout metastases of a given size. A biopsy of the metastatic site will also be obtained to validate expression of the receptor CD155.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate, renal cell carcinoma or urothelial carcinoma. Small cell or neuroendocrine tumors of the prostate are also permitted.
- •Radiographic evidence of at least one bone, lymph node, soft tissue, or liver metastasis, that is amenable to iodinated contrast injection, as judged by the study radiologist
- •Adequate laboratory values:
- •Platelets ≥ 100,000
- •Age > 18 years.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •History of intercurrent or past medical or psychiatric illness that would make participation in a research biopsy protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
- •History of iodinated contrast allergy
- •For patients undergoing research only biopsy: Requirement for anticoagulation with heparin, low molecular weight heparin, clopidogrel, rivaroxaban, dabigatran, apixaban, warfarin, Aggrenox, fondaparux, ticagrelor, etc (aspirin and other NSAIDs are ok but should be held prior to biopsy in accordance with institutional standard of care)
- •Any other contraindication to CT with iodinated contrast, as CT with contrast will be used in the study.
研究组 & 干预措施
Bone metastatic site
干预措施: Isovue-M 200 (Drug)
Liver metastatic site
干预措施: Isovue-M 200 (Drug)
Lymph node metastatic site
干预措施: Isovue-M 200 (Drug)
Soft tissue metastatic site
干预措施: Isovue-M 200 (Drug)
结局指标
主要结局
Percentage of iodinated contrast enhancement within the metastasis on post-injection CT
时间窗: Day 1
Presence of iodinated contrast enhancement within the metastasis on post-injection CT
时间窗: Day 1
次要结局
- Presence of tumor CD155 membrane expression in metastatic bone, liver, soft tissue or lymph node specimens.(Day 1)
- Estimated percentage of tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.(Day 1)