Clinical Trial: S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Prospective Observational Study of Patients With Solitary Plasmacytoma Using a Modified Staging System Supplemented by an MRI and Whole Body FDG-PET Scan

Brief Summary:

RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) and fludeoxyglucose F 18 positron emission tomography (^18FDG-PET) may help diagnose solitary plasmacytoma.

PURPOSE: This clinical trial is studying MRI and ^18FDG-PET to see how well they work in diagnosing patients with solitary plasmacytoma.


Detailed Summary:

OBJECTIVES:

  • Determine the proportion of patients who are misclassified as true solitary plasmacytoma by MRI and whole-body fludeoxyglucose F 18 positron emission tomography as a supplement to imaging with skeletal survey.
  • Determine the feasibility of accruing patients to this study.
  • Determine, preliminarily, biological correlates and prognostic groups that may relate to progression to symptomatic disease in patients undergoing these imaging procedures.
  • Correlate germline genetic polymorphisms with overall clinical course in patients undergoing these imaging procedures.

OUTLINE: This is a multicenter study.

Within 28 days after study entry, patients undergo gadolinium MRI of the head, spine, and pelvis (and other sites, if indicated). Patients then receive fludeoxyglucose F 18 IV followed 90 minutes later by whole-body positron emission tomography (^18FDG-PET) OR whole-body CT scan/PET. Patients with a confirmed diagnosis of solitary plasmacytoma undergo MRI and ^18FDG-PET as above at 1 year and then annually for 10 years in the absence of disease progression (i.e., change of status to solitary plasmacytoma with active myeloma or biopsy confirmed stage IB or higher multiple myeloma).

After completion of study procedures, patients are followed every 6 months for 10 years.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study.


Sponsor: Southwest Oncology Group

Current Primary Outcome: proportion of patients misclassified as solitary plasmacytoma [ Time Frame: 2 months ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Southwest Oncology Group

Dates:
Date Received: May 3, 2005
Date Started: April 2005
Date Completion:
Last Updated: April 21, 2017
Last Verified: April 2017