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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2009 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00589537
First received: December 25, 2007
Last updated: August 6, 2013
Last verified: July 2009

December 25, 2007
August 6, 2013
March 2008
December 2016   (final data collection date for primary outcome measure)
Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00589537 on ClinicalTrials.gov Archive Site
  • Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI) [ Designated as safety issue: No ]
  • Time on surveillance before detection of relapse [ Designated as safety issue: No ]
  • Prospective identification of first modality to detect relapse (patient symptom, clinical examination, tumor marker, chest x-ray, cross-sectional image) [ Designated as safety issue: No ]
  • Extent of relapse according to International Germ Cell Cancer Collaborative Group classification [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Prospective evaluation of prognostic factors for relapse [ Designated as safety issue: No ]
  • Number of false positive MRIs [ Designated as safety issue: No ]
  • Resource use and costs [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Magnetic Resonance Imaging and Computed Tomography in Patients With Stage I Seminoma of the Testicle
Trial of Imaging and Schedule in Seminoma Testis

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Diagnostic
Testicular Germ Cell Tumor
  • Other: questionnaire administration
  • Procedure: computed tomography
  • Procedure: magnetic resonance imaging
  • Procedure: quality-of-life assessment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
660
Not Provided
December 2016   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed seminoma of the testis

    • Stage I disease, as determined by clinical examination and CT scan of the chest, abdomen, and pelvis
  • No evidence of any non-seminoma germ cell tumor elements
  • Has undergone orchidectomy within the past 8 weeks

    • Normal serum alpha-fetoprotein pre-orchidectomy and at study randomization
    • Normal serum beta human chorionic gonadotrophin at study randomization (may have been elevated pre-orchidectomy)
  • Not planning to undergo adjuvant therapy

PATIENT CHARACTERISTICS:

  • Able to attend regular surveillance
  • No other malignancy within the past 10 years expect successfully treated nonmelanoma skin cancer
  • No contraindication to MRI (i.e., ferrous metal implants of any type, cardiac pacemaker or defibrillator, or history of injury by metal fragments)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Male
16 Years and older
No
United Kingdom
 
NCT00589537
MRC-NCRI-TRISST-TE24, CDR0000574037, EU-20771, ISRCTN65987321
Not Provided
Not Provided
Medical Research Council
Not Provided
Study Chair: Johnathan Joffe, MD Huddersfield Royal Infirmary
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP