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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA032102 | U.S. NIH Grant/Contract | View source | |
| S0340 | Other Identifier | SWOG |
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poor accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI and PET | Other | Magnetic resonance imaging and positron emission tomography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnetic resonance imaging | Procedure | magnetic resonance imaging (MRI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients misclassified as solitary plasmacytoma | 2 months |
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DISEASE CHARACTERISTICS:
Histologically confirmed solitary plasmacytoma of 1 of the following types:
Bone marrow plasmacytosis < 10% within the past 4 weeks
Low serum and/or urine M-protein meeting ≥ 1 of the following criteria:
No lytic lesions on skeletal survey other than a single lesion associated with solitary plasmacytoma within the past 4 weeks
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Andrzej J. Jakubowiak, MD, PhD | University of Michigan Rogel Cancer Center | Study Chair |
| Janet S. Biermann, MD | University of Michigan Rogel Cancer Center | Study Chair |
| Paul Okunieff, MD | James P. Wilmot Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36652-2144 | United States | ||
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences |
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| positron emission tomography | Procedure | positron emission tomography (PET) |
|
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Tammy Walker Cancer Center at Salina Regional Health Center | Salina | Kansas | 67401 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59101 | United States |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare | Billings | Montana | 59101 | United States |
| Billings Clinic Cancer Center | Billings | Montana | 59107-5100 | United States |
| Deaconess Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | United States |
| St. James Community Hospital | Butte | Montana | 59701 | United States |
| Big Sky Oncology | Great Falls | Montana | 59405 | United States |
| Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls | Montana | 59405 | United States |
| St. Peter's Hospital | Helena | Montana | 59601 | United States |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | United States |
| Kalispell Medical Oncology | Kalispell | Montana | 59901 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Community Medical Center | Missoula | Montana | 59801 | United States |
| Guardian Oncology and Center for Wellness | Missoula | Montana | 59804 | United States |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | United States |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59807 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Wayne Radiation Oncology | Goldsboro | North Carolina | 27534 | United States |
| Wilson Medical Center | Wilson | North Carolina | 27893-3428 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D010954 | Plasmacytoma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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