Spots Global Cancer Trial Database for S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma
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Trial Identification
Brief Title: S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma
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 ID: NCT00109889
Study Description
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.
Detailed Description: 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mobile Infirmary Medical Center, Mobile, Alabama, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center, Salina, Kansas, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
St. Vincent Healthcare, Billings, Montana, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Deaconess Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
St. James Community Hospital, Butte, Montana, United States
Big Sky Oncology, Great Falls, Montana, United States
Sletten Regional Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology, Kalispell, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Community Medical Center, Missoula, Montana, United States
Guardian Oncology and Center for Wellness, Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Wayne Radiation Oncology, Goldsboro, North Carolina, United States
Wilson Medical Center, Wilson, North Carolina, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States
Contact Details
Name: Andrzej J. Jakubowiak, MD, PhD
Affiliation: University of Michigan Rogel Cancer Center
Role: STUDY_CHAIR
Name: Janet S. Biermann, MD
Affiliation: University of Michigan Rogel Cancer Center
Role: STUDY_CHAIR
Name: Paul Okunieff, MD
Affiliation: James P. Wilmot Cancer Center
Role: STUDY_CHAIR
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