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Brief Title: Positron Emission Tomography in Detecting Testicle Cancer
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 ID: NCT00045045
Brief Summary: 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.
Detailed Description: 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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Royal Devon and Exeter Hospital, Exeter, England, United Kingdom
Ipswich Hospital NHS Trust, Ipswich, England, United Kingdom
Guy's and St. Thomas' Hospitals NHS Foundation Trust, London, England, United Kingdom
Meyerstein Institute of Oncology at University College of London Hospitals, London, England, United Kingdom
Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom
Royal South Hants Hospital, Southampton, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey, Sutton, England, United Kingdom
Beatson Oncology Centre, Glasgow, Scotland, United Kingdom
Name: Robert A. Huddart, MD
Affiliation: Royal Marsden NHS Foundation Trust
Role: STUDY_CHAIR