Positron Emission Tomography in Detecting Testicle Cancer
A Study Of 18 FDG PET In The Prediction Of Relapse In Patients With A Clinical Stage I Non-Seminomatous Germ Cell Tumor
RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to detect the extent of cancer and allow doctors to plan more effective treatment for patients who have testicle cancer.
PURPOSE: Diagnostic trial to study the effectiveness of positron emission tomography using fludeoxyglucose F 18 in predicting relapse in patients who have stage I germ cell tumor of the testicle.
研究概览
详细说明
OBJECTIVES:
- Assess the ability of fludeoxyglucose F 18 positron emission tomography to predict relapse requiring adjuvant chemotherapy in patients with high-risk stage I non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis who are on current management protocols.
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (FDG) IV followed 1 hour later by positron emission tomography (PET) imaging. Patients with metastatic disease identified by FDG PET imaging may receive adjuvant chemotherapy according to the standard clinical practice at each participating center. Patients with no metastatic disease identified by FDG PET imaging are considered for entry into the MRC-TE08 trial (randomized trial of 2 CT scan frequencies in the surveillance of stage I teratoma) or are followed according to the standard surveillance schedule.
Patients with metastatic disease are followed every 6 months. Patients with no metastatic disease are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 4-6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 135 patients will be accrued for this study within 2-3 years.
研究类型
阶段
- 不适用
联系人和位置
学习地点
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England
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Exeter、England、英国、EX2 5DW
- Royal Devon and Exeter Hospital
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Ipswich、England、英国、IP4 5PD
- Ipswich Hospital NHS Trust
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London、England、英国、SE1 9RT
- Guy's and St. Thomas' Hospitals NHS Foundation Trust
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London、England、英国、WIT 3AA
- Meyerstein Institute of Oncology at University College of London Hospitals
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Nottingham、England、英国、NG5 1PB
- Nottingham City Hospital NHS Trust
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Southampton、England、英国、5O14OYG
- Royal South Hants Hospital
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Sutton、England、英国、SM2 5PT
- Royal Marsden NHS Foundation Trust - Surrey
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Scotland
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Glasgow、Scotland、英国、G11 6NT
- Beatson Oncology Centre
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
- Histologically confirmed non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis with evidence of vascular (lymphatic or venous) invasion in primary specimen
- Clinical stage I on the basis of clinical examination, chest x-ray, and CT scan of the chest, abdomen, and pelvis
- Negative post-orchidectomy tumor markers (alpha-fetoprotein and beta human chorionic gonadotropin)
- High-risk disease
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- No evidence of active inflammatory or infective diseases
- No other disease or prior malignancy that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
- No more than 8 weeks since prior orchidectomy
Other
- No prior positron emission tomography scans
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
合作者和调查者
调查人员
- 学习椅:Robert A. Huddart, MD、Royal Marsden NHS Foundation Trust
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- CDR0000256314
- MRC-TE22
- EU-20115
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氟脱氧葡萄糖 F 18的临床试验
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John M. BuattiNational Cancer Institute (NCI); National Institutes of Health (NIH)完全的