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临床试验/NCT02826395
NCT02826395No Longer Available不适用

Carbon-11 Sodium Acetate PET/CT Imaging of Prostate Cancer

Jonsson Comprehensive Cancer Center1 个研究点 分布在 1 个国家开始时间: 2016年7月11日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
No Longer Available
试验地点
1

研究概览

简要总结

The investigators propose to conduct Carbon-11 Sodium Acetate PET/CT studies. The purpose of our study is to evaluate the impact of Carbon-11 Sodium Acetate PET/CT studies on patient management in patients with prostate cancer.

详细描述

This is an expanded access study under an IND with a total of 300 participants with prostate cancer. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 11C-Sodium Acetate and will undergo a PET/CT imaging study. All patients referred by Oncologists and Urologists will be screened by a UCLA Nuclear Medicine physician and then accepted for scanning if clinically appropriate. The following steps will take place.

  1. Informed consent will be obtained.
  2. Vital signs (heart rate, blood pressure, respiratory rate, pulse oxymetry) will be recorded.
  3. Participant will be injected with 20 - 40mCi of 11C-Sodium Acetate intravenously (i.v.).
  4. PET/CT Scans will be performed with or without oral and IV contrast. All investigational scans will be read by at least one board-certified nuclear medicine physician with established expertise in PET/CT of at least 5 years' experience. Fifteen minutes after injection of 11C-Sodium Acetate, the investigators will acquire a scan. Emission images will be acquired for 3-5min/bed position. Intravenous and oral contrast will be given for the CT portion of the study.
  5. Vital signs (heart rate, blood pressure, respiratory rate, pulse oxymetry) will be recorded following the completion of the scan.
  6. Within 24-48 hours of PET/CT imaging, a follow-up telephone call or email will be conducted to discuss any side effects or reactions to the investigational agent.

研究设计

研究类型
Expanded Access

入排标准

性别
Male
接受健康志愿者

入选标准

  • Diagnosed prostate cancer
  • Able to remain still for duration of each imaging procedure (about 30 minutes)

排除标准

  • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
  • Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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