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S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00109889
Recruitment Status : Terminated (poor accrual)
First Posted : May 4, 2005
Last Update Posted : April 24, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Plasmacytoma Procedure: magnetic resonance imaging Procedure: positron emission tomography Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Study Start Date : April 2005
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Arm Intervention/treatment
Magnetic resonance imaging and positron emission tomography
Procedure: magnetic resonance imaging
magnetic resonance imaging (MRI)
Other Name: MRI
Procedure: positron emission tomography
positron emission tomography (PET)
Other Name: PET

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


  • 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


  • Not specified


  • Calcium ≤ 10.5 mg/dL OR
  • Calcium normal
  • Creatinine ≤ 2 mg/dL


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • No prior high-dose steroids except to relieve neurological compromise


  • Prior localized radiotherapy for myeloma allowed
  • Concurrent radiotherapy allowed


  • Prior surgery for myeloma allowed


  • No other prior therapy for myeloma
  • Concurrent enrollment in protocol SWOG-S0309 (Myeloma Specimen Repository) allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109889

United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Kansas
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States, 67401
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. Vincent Healthcare
Billings, Montana, United States, 59101
Billings Clinic Cancer Center
Billings, Montana, United States, 59107-5100
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
St. James Community Hospital
Butte, Montana, United States, 59701
Big Sky Oncology
Great Falls, Montana, United States, 59405
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Community Medical Center
Missoula, Montana, United States, 59801
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Wilson Medical Center
Wilson, North Carolina, United States, 27893-3428
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Andrzej J. Jakubowiak, MD, PhD University of Michigan Cancer Center
Study Chair: Janet S. Biermann, MD University of Michigan Cancer Center
Study Chair: Paul Okunieff, MD James P. Wilmot Cancer Center

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00109889     History of Changes
Other Study ID Numbers: CDR0000426422
U10CA032102 ( U.S. NIH Grant/Contract )
S0340 ( Other Identifier: SWOG )
First Posted: May 4, 2005    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017

Keywords provided by Southwest Oncology Group:
extramedullary plasmacytoma
isolated plasmacytoma of bone

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases