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S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma

Phase 2
Terminated
Conditions
Plasmacytoma
Multiple Myeloma
Interventions
Procedure: magnetic resonance imaging
Procedure: positron emission tomography
Registration Number
NCT00109889
Lead Sponsor
SWOG Cancer Research Network
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 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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
2
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
MRI and PETmagnetic resonance imagingMagnetic resonance imaging and positron emission tomography
MRI and PETpositron emission tomographyMagnetic resonance imaging and positron emission tomography
Primary Outcome Measures
NameTimeMethod
proportion of patients misclassified as solitary plasmacytoma2 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (26)

Bozeman Deaconess Cancer Center

🇺🇸

Bozeman, Montana, United States

CCOP - Montana Cancer Consortium

🇺🇸

Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings

🇺🇸

Billings, Montana, United States

Northern Rockies Radiation Oncology Center

🇺🇸

Billings, Montana, United States

St. Vincent Healthcare

🇺🇸

Billings, Montana, United States

Deaconess Billings Clinic - Downtown

🇺🇸

Billings, Montana, United States

University of Michigan Comprehensive Cancer Center

🇺🇸

Ann Arbor, Michigan, United States

Wayne Radiation Oncology

🇺🇸

Goldsboro, North Carolina, United States

Wilson Medical Center

🇺🇸

Wilson, North Carolina, United States

Mobile Infirmary Medical Center

🇺🇸

Mobile, Alabama, United States

Community Medical Center

🇺🇸

Missoula, Montana, United States

St. James Community Hospital

🇺🇸

Butte, Montana, United States

Kalispell Medical Oncology

🇺🇸

Kalispell, Montana, United States

Guardian Oncology and Center for Wellness

🇺🇸

Missoula, Montana, United States

Montana Cancer Specialists at Montana Cancer Center

🇺🇸

Missoula, Montana, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

🇺🇸

Missoula, Montana, United States

Big Sky Oncology

🇺🇸

Great Falls, Montana, United States

Sletten Regional Cancer Institute at Benefis Healthcare

🇺🇸

Great Falls, Montana, United States

Glacier Oncology, PLLC

🇺🇸

Kalispell, Montana, United States

Welch Cancer Center at Sheridan Memorial Hospital

🇺🇸

Sheridan, Wyoming, United States

Tammy Walker Cancer Center at Salina Regional Health Center

🇺🇸

Salina, Kansas, United States

Billings Clinic Cancer Center

🇺🇸

Billings, Montana, United States

Kalispell Regional Medical Center

🇺🇸

Kalispell, Montana, United States

St. Peter's Hospital

🇺🇸

Helena, Montana, United States

Wayne Memorial Hospital, Incorporated

🇺🇸

Goldsboro, North Carolina, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

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