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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Trial of Imaging and Schedule in Seminoma Testis

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 Summary:

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.


Sponsor: Medical Research Council

Current Primary Outcome: Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: December 25, 2007
Date Started: March 2008
Date Completion:
Last Updated: August 6, 2013
Last Verified: July 2009