Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00589537|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : January 9, 2008
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Testicular Germ Cell Tumor||Other: questionnaire administration Procedure: computed tomography Procedure: magnetic resonance imaging Procedure: quality-of-life assessment||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||660 participants|
|Official Title:||Trial of Imaging and Schedule in Seminoma Testis|
|Study Start Date :||March 2008|
|Estimated Primary Completion Date :||December 2016|
- Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease
- Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI)
- Time on surveillance before detection of relapse
- Prospective identification of first modality to detect relapse (patient symptom, clinical examination, tumor marker, chest x-ray, cross-sectional image)
- Extent of relapse according to International Germ Cell Cancer Collaborative Group classification
- Disease-free survival
- Overall survival
- Prospective evaluation of prognostic factors for relapse
- Number of false positive MRIs
- Resource use and costs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589537
|Study Chair:||Johnathan Joffe, MD||Huddersfield Royal Infirmary|