A Prospective Observational Study of Patients With Solitary Plasmacytoma Using a Modified Staging System Supplemented by an MRI and Whole Body FDG-PET Scan
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label
proportion of patients misclassified as solitary plasmacytoma
Andrzej J. Jakubowiak, MD, PhD
University of Michigan Cancer Center
United States: Federal Government
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|CCOP - Montana Cancer Consortium||Billings, Montana 59101|
|Mobile Infirmary Medical Center||Mobile, Alabama 36640-0460|
|Arkansas Cancer Research Center at University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Northern Rockies Radiation Oncology Center||Billings, Montana 59101|
|Hematology-Oncology Centers of the Northern Rockies - Billings||Billings, Montana 59101|
|St. Vincent Healthcare||Billings, Montana 59101|
|Deaconess Billings Clinic - Downtown||Billings, Montana 59101|
|St. James Community Hospital||Butte, Montana 59701|
|Big Sky Oncology||Great Falls, Montana 59405|
|St. Peter's Hospital||Helena, Montana 59601|
|Kalispell Medical Oncology||Kalispell, Montana 59901|
|Kalispell Regional Medical Center||Kalispell, Montana 59901|
|Glacier Oncology, PLLC||Kalispell, Montana 59901|
|Montana Cancer Center at St. Patrick Hospital and Health Sciences Center||Missoula, Montana 59802|
|Montana Cancer Specialists at Montana Cancer Center||Missoula, Montana 59802|
|Community Medical Center||Missoula, Montana 59801|
|Wayne Memorial Hospital, Incorporated||Goldsboro, North Carolina 27534|
|Wayne Radiation Oncology||Goldsboro, North Carolina 27534|
|Wilson Medical Center||Wilson, North Carolina 27893-3428|
|Welch Cancer Center at Sheridan Memorial Hospital||Sheridan, Wyoming 82801|
|Tammy Walker Cancer Center at Salina Regional Health Center||Salina, Kansas 67401|
|Bozeman Deaconess Cancer Center||Bozeman, Montana 59715|
|Billings Clinic Cancer Center||Billings, Montana 59107-5100|
|Sletten Regional Cancer Institute at Benefis Healthcare||Great Falls, Montana 59405|
|Guardian Oncology and Center for Wellness||Missoula, Montana 59804|