Positron Emission Tomography in Detecting Testicle Cancer
|ClinicalTrials.gov Identifier: NCT00045045|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment|
|Testicular Germ Cell Tumor||Procedure: positron emission tomography Radiation: fludeoxyglucose F 18|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Study Of 18 FDG PET In The Prediction Of Relapse In Patients With A Clinical Stage I Non-Seminomatous Germ Cell Tumor|
|Study Start Date :||May 2002|
|Study Completion Date :||July 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045045
|Royal Devon and Exeter Hospital|
|Exeter, England, United Kingdom, EX2 5DW|
|Ipswich Hospital NHS Trust|
|Ipswich, England, United Kingdom, IP4 5PD|
|Guy's and St. Thomas' Hospitals NHS Foundation Trust|
|London, England, United Kingdom, SE1 9RT|
|Meyerstein Institute of Oncology at University College of London Hospitals|
|London, England, United Kingdom, WIT 3AA|
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Royal South Hants Hospital|
|Southampton, England, United Kingdom, 5O14OYG|
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Beatson Oncology Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||Robert A. Huddart, MD||Royal Marsden NHS Foundation Trust|