ISRCTN66828876已完成未知
A pilot study investigating the sensitivity of 18F-labelled sodium fluoride positron emission tomography - computed tomography (PET-CT) for detecting skeletal metastases in renal cell carcinoma compared to planar bone scintigraphy and multidetector computed tomography (CT)
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge (UK) - Joint Sponsorship0 个研究点目标入组 20 人开始时间: 2011年4月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/26202597 (added 16/01/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female, 18 years of age or older with no upper age limit
- •2. Must be able to provide a written informed consent according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (ICH/GCP), national and local regulations
- •3. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment
- •4. Treatment-naïve patients in the first instance. If at 6 months, insufficient numbers (less than 5) can be recruited in the time period between diagnosis and treatment, then patients that have been treated will also be recruited after the first cycle of chemotherapy.
- •5. Life expectancy of 12 weeks or greater
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 7. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
排除标准
- •1. Diagnosis of any other malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer
- •2. Allergy to methylene diphosphonate used in bone scintigraphy
- •3. Any metabolic disorder that involves the skeletal system
- •4. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
- •5. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment.
- •6. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or in the judgment of the investigator would make it undesirable for the patient to enter the trial
- •7. Not suitable to undergo a PET study, e.g., extreme obesity: greater than 226 kg
研究者
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A Pilot Study Investigating the Sensitivity of 18F-labelled Sodium Fluoride PET-CT for Detecting Skeletal Metastases in Renal Cell Carcinoma compared to Planar Bone Scintigraphy and Multidetector CT - 18F-Fluoride PET-CT for Detecting Bone Metastases in RCCEUCTR2010-024624-20-GBCambridge University Hospitals NHS Foundation Trust and University of Cambridge
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