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Clinical Trial: Magnetic Resonance Imaging and Fludeoxyglucose F18 Positron Emission Tomography in Diagnosing Patients With Plasmacytoma
This study is not yet open for patient recruitment.
Purpose
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) and fludeoxyglucose F 18 positron emission tomography (18FDG-PET) may help diagnose plasmacytoma.
PURPOSE: This clinical trial is studying MRI and 18FDG-PET to see how well they work in diagnosing patients with plasmacytoma.
| Condition | Treatment or Intervention |
|---|---|
| extramedullary plasmacytoma isolated plasmacytoma of bone | Drug: fludeoxyglucose F 18 Procedure: computed tomography Procedure: diagnostic test Procedure: magnetic resonance imaging Procedure: tomography, emission computed |
MedlinePlus related topics: Multiple Myeloma
Study Type: Interventional
Study Design: Diagnostic
Official Title: Diagnostic Study of MRI and Whole-Body Fludeoxyglucose F 18 Positron Emission Tomography in Patients With Solitary Plasmacytoma
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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 provided radiotherapy was initiated within the past 84 days
- Concurrent radiotherapy allowed
Surgery
Other
- No other prior therapy for myeloma
- Concurrent enrollment in protocol SWOG-S0309 (Myeloma Specimen Repository) allowed
Location and Contact Information
Andrzej J. Jakubowiak, MD, Study Chair, University of Michigan Comprehensive Cancer Center
J. Sybil Biermann, MD, University of Michigan Comprehensive Cancer Center
Paul Okunieff, MD, James P. Wilmot Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2005
Last Updated: May 11, 2005
Record first received: May 3, 2005
ClinicalTrials.gov Identifier: NCT00109889
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-17
Source: ClinicalTrials.gov
Cache Date: May 18, 2005
Resources
- Electric And Magnetic Fields (National Women's Health Information Center)
- EMF (Electric and Magnetic Fields): Questions and Answers (National Institute of Environmental Health Sciences)

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