S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma
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| First Received Date ICMJE | May 3, 2005 | ||||||||||||
| Last Updated Date | April 2, 2012 | ||||||||||||
| Start Date ICMJE | April 2005 | ||||||||||||
| Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
proportion of patients misclassified as solitary plasmacytoma [ Time Frame: 2 months ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | Complete list of historical versions of study NCT00109889 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma | ||||||||||||
| Official Title ICMJE | A Prospective Observational Study of Patients With Solitary Plasmacytoma Using a Modified Staging System Supplemented by an MRI and Whole Body FDG-PET Scan | ||||||||||||
| 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. |
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| Detailed Description | 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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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 2 | ||||||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | MRI and PET
Magnetic resonance imaging and positron emission tomography
Interventions:
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Terminated | ||||||||||||
| Enrollment ICMJE | 2 | ||||||||||||
| Estimated Completion Date | February 2017 | ||||||||||||
| Primary Completion Date | April 2007 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
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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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00109889 | ||||||||||||
| Other Study ID Numbers ICMJE | CDR0000426422, U10CA032102, S0340 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Southwest Oncology Group | ||||||||||||
| Study Sponsor ICMJE | Southwest Oncology Group | ||||||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Southwest Oncology Group | ||||||||||||
| Verification Date | April 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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