S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Plasmacytoma, Multiple Myeloma

Intervention / Treatment
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* Procedure: magnetic resonance imaging
* Procedure: positron emission tomography


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed solitary plasmacytoma of 1 of the following types: Solitary bone plasmacytoma Extraosseus solitary plasmacytoma Bone marrow plasmacytosis < 10% within the past 4 weeks Low serum and/or urine M-protein meeting ≥ 1 of the following criteria: Serum IgG < 3.5 g/dL Serum IgA < 2.0 g/dL Urine M-protein (kappa or lambda) < 1.0 g/24 hours No lytic lesions on skeletal survey other than a single lesion associated with solitary plasmacytoma within the past 4 weeks PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Hemoglobin ≥ 10 g/dL* AND/OR No hemoglobin 2 g/dL < lower limit of normal* (LLN) NOTE: *Patients with a history of hemoglobin < 10 g/dL AND/OR < 2 g/dL < LLN that has corrected or improved after epoetin alfa but requires continued treatment with epoetin alfa are not eligible Hepatic Not specified Renal Calcium ≤ 10.5 mg/dL OR Calcium normal Creatinine ≤ 2 mg/dL Other No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or stage I or II cancer that is currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy No prior high-dose steroids except to relieve neurological compromise Radiotherapy Prior localized radiotherapy for myeloma allowed Concurrent radiotherapy allowed Surgery Prior surgery for myeloma allowed Other No other prior therapy for myeloma Concurrent enrollment in protocol SWOG-S0309 (Myeloma Specimen Repository) allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRI and PET<br>Magnetic resonance imaging and positron emission tomography | Procedure: magnetic resonance imaging<br>* magnetic resonance imaging (MRI)<br>* Other names: MRI;Procedure: positron emission tomography<br>* positron emission tomography (PET)<br>* Other names: PET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients misclassified as solitary plasmacytoma |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extramedullary plasmacytoma, isolated plasmacytoma of bone