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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00109889 |
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 | Intervention |
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Multiple Myeloma and Plasma Cell Neoplasm |
Procedure: computed tomography Procedure: magnetic resonance imaging Procedure: positron emission tomography Radiation: fludeoxyglucose F 18 |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label |
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 |
Estimated Enrollment: | 110 |
Study Start Date: | April 2005 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solitary plasmacytoma of 1 of the following types:
Low serum and/or urine M-protein meeting ≥ 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 | |
Big Sky Oncology | |
Great Falls, Montana, United States, 59405 | |
Billings Clinic Cancer Center | |
Billings, Montana, United States, 59107-5100 | |
Hematology-Oncology Centers of the Northern Rockies - Billings | |
Billings, Montana, United States, 59101 | |
CCOP - Montana Cancer Consortium | |
Billings, Montana, United States, 59101 | |
Community Medical Center | |
Missoula, Montana, United States, 59801 | |
Deaconess Billings Clinic - Downtown | |
Billings, Montana, United States, 59107-7000 | |
Glacier Oncology, PLLC | |
Kalispell, Montana, United States, 59901 | |
Guardian Oncology and Center for Wellness | |
Missoula, Montana, United States, 59804 | |
Bozeman Deaconess Cancer Center | |
Bozeman, Montana, United States, 59715 | |
Kalispell Medical Oncology | |
Kalispell, Montana, United States, 59901 | |
Kalispell Regional Medical Center | |
Kalispell, Montana, United States, 59901 | |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
Missoula, Montana, United States, 59807 | |
Montana Cancer Specialists at Montana Cancer Center | |
Missoula, Montana, United States, 59807-7877 | |
St. James Community Hospital | |
Butte, Montana, United States, 59701 | |
Sletten Regional Cancer Institute at Benefis Healthcare | |
Great Falls, Montana, United States, 59405 | |
Northern Rockies Radiation Oncology Center | |
Billings, Montana, United States, 59101 | |
St. Peter's Hospital | |
Helena, Montana, United States, 59601 | |
St. Vincent Healthcare | |
Billings, Montana, United States, 59101 | |
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 |
Study Chair: | Andrzej J. Jakubowiak, MD, PhD | University of Michigan Cancer Center |
Investigator: | Janet S. Biermann, MD | University of Michigan Cancer Center |
Investigator: | Paul Okunieff, MD | James P. Wilmot Cancer Center |
Study ID Numbers: | CDR0000426422, SWOG-S0340 |
Study First Received: | May 3, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00109889 History of Changes |
Health Authority: | United States: Federal Government |
extramedullary plasmacytoma isolated plasmacytoma of bone |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Hemorrhagic Disorders Plasmacytoma Plasmacytoma Anaplastic Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Neoplasms Hemorrhagic Disorders Plasmacytoma Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |