Spots Global Cancer Trial Database for Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle
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Trial Identification
Brief Title: Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle
Official Title: Trial of Imaging and Schedule in Seminoma Testis
Study ID: NCT00589537
Conditions
Study Description
Brief Summary: RATIONALE: Imaging procedures, such as MRI and CT scan, may find recurrent cancer. It is not yet known which MRI or CT scan schedule is more effective in finding recurrent cancer. PURPOSE: This randomized phase III trial is comparing four different MRI and CT scan schedules in patients with stage I seminoma of the testicle.
Detailed Description: OBJECTIVES: * To assess whether a reduced computed tomography (CT) schedule or magnetic resonance imaging (MRI) could be used as safe and effective alternatives to standard CT-based surveillance in the management of patients with stage I seminoma of the testis. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 surveillance arms. * Arm I: Patients undergo computed tomography (CT) scan of the abdomen/retroperitoneum\* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression. * Arm II: Patients undergo CT scan of the abdomen/retroperitoneum\* at 6, 18, and 36 months in the absence of disease progression. * Arm III: Patients undergo magnetic resonance imaging (MRI) of the abdomen/retroperitoneum\* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression. * Arm IV: Patients undergo MRI of the abdomen/retroperitoneum\* at 6, 18, and 36 months in the absence of disease progression. NOTE: \*Patients with a history of ipsilateral inguino-scrotal surgery also undergo imaging of the pelvis. Patients complete questionnaires at baseline and periodically during study to assess health-related quality of life; utilization and cost of healthcare services (including the cost of CT- or MRI-based surveillance and the management of any recurrence); and acceptability of allocated scanning schedule. Patients are followed every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 3 years.
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Royal Bournemouth Hospital, Bournemouth, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital, Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom
Addenbrooke's Hospital, Cambridge, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital, Cheltenham, England, United Kingdom
Huddersfield Royal Infirmary, Huddersfield, West Yorks, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom
Leicester Royal Infirmary, Leicester, England, United Kingdom
Lincoln County Hospital, Lincoln, England, United Kingdom
UCL Cancer Institute, London, England, United Kingdom
Charing Cross Hospital, London, England, United Kingdom
University College of London Hospitals, London, England, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital, Maidstone, England, United Kingdom
Christie Hospital, Manchester, England, United Kingdom
James Cook University Hospital, Middlesbrough, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital, Newcastle-Upon-Tyne, England, United Kingdom
Northampton General Hospital, Northampton, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood, England, United Kingdom
Nottingham City Hospital, Nottingham, England, United Kingdom
Churchill Hospital, Oxford, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital, Reading, England, United Kingdom
Cancer Research Centre at Weston Park Hospital, Sheffield, England, United Kingdom
Royal Marsden - Surrey, Sutton, England, United Kingdom
Yeovil District Hospital, Yeovil, England, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast, Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital, Cardiff, Wales, United Kingdom
Glan Clwyd Hospital, Rhyl, Denbighshire, Wales, United Kingdom
Contact Details
Name: Johnathan Joffe, MD
Affiliation: Huddersfield Royal Infirmary
Role: STUDY_CHAIR
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