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临床试验/NCT03542773
NCT03542773已完成1 期

Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2015年2月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
38
试验地点
1
主要终点
Determine feasibility of using 18F-DCFPyL to detect cancer

研究概览

简要总结

To use 18F-DCFPyL imaging agent and PET/CT to detect none prostate cancer solid malignancies and schwannoma tumors.

详细描述

The purpose of this protocol is to extend our existing patient base from those with prostate cancer to those with any solid malignancy - as well as patients with schwannoma, a non-malignant solid tumor that also over-expresses GCP II. Using our first generation imaging agent, [18F]DCFBC, we have shown that we could detect GCP II in tissue specimens of patients with a variety of cancers, and vestibular schwannoma. We have also shown that GCP II may not only be present in the neovasculature of solid (non-prostate) tumors, but also reside within the tumor epithelium itself. We have shown that to be the case for melanoma, in particular. Our goal is to leverage the broad utility of our GCP II targeted imaging agents for managing other cancers. In addition to schwannoma, the cancers we intend to target include but will not be restricted to: head and neck cancer, salivary gland tumors, renal cell carcinoma, transitional cell carcinoma, colorectal cancer, gastric cancer, neuroendocrine cancer, glioblastoma, melanoma, pancreatic cancer, non-small cell lung cancer, soft tissue sarcoma, breast cancer, endometrial cancer, ovarian cancer, lymphoma and multiple myeloma.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Greater than or equal to 18 years of age
  • Biopsy-proven cancer or Schwannoma diagnosis
  • No contraindications to PET scanning to include pregnancy, etc. For females of childbearing potential, negative serum pregnancy test obtained within a 10-day period prior to PET study
  • Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

排除标准

  • Administered a radioisotope within 5 physical half-lives prior to PET imaging
  • In female subjects pregnancy.

研究组 & 干预措施

18F-DCFPyL

Experimental

A bolus of less than or equal to 9 mCi (331 MBq) of IV injection of 18F-DCFPyL

干预措施: 18F-DCFPyL Injection (Drug)

结局指标

主要结局

Determine feasibility of using 18F-DCFPyL to detect cancer

时间窗: 24 months

The primary objective of this project is to test the feasibility of 18F-DCFPyL to detect cancer. The visual assessment of suspected tumor will be considered positive if there is sustained radiotracer activity over expected soft tissue or blood pool physiologic activity levels and recorded as mild (above blood pool), moderate (above blood pool, but less than liver), or intense (at or above the liver). Feasibility will be determined based on number of positively recognized regions of interest.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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