NCT00589537

Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle

Trial of Imaging and Schedule in Seminoma Testis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: Male
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
OTHER	questionnaire administration
PROCEDURE	computed tomography
PROCEDURE	magnetic resonance imaging
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2008-03-01
• Primary completion: 2016-12-01
• First posted: 2008-01-09
• Last updated: 2013-08-07

Locations

29 sites across 1 country: United Kingdom