NCT00109889

S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Multiple Myeloma
• Plasmacytoma

Interventions

Type	Name	Description
PROCEDURE	magnetic resonance imaging	magnetic resonance imaging (MRI)
PROCEDURE	positron emission tomography	positron emission tomography (PET)

Timeline

• Start date: 2005-04-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2005-05-04
• Last updated: 2017-04-24

Locations

26 sites across 1 country: United States