A Prospective Observational Study of Patients With Solitary Plasmacytoma Using a Modified Staging System Supplemented by an MRI and Whole Body FDG-PET Scan
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 26
- 主要终点
- proportion of patients misclassified as solitary plasmacytoma
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed solitary plasmacytoma of 1 of the following types:
- •Solitary bone plasmacytoma
- •Extraosseus solitary plasmacytoma
- •Bone marrow plasmacytosis < 10% within the past 4 weeks
- •Low serum and/or urine M-protein meeting ≥ 1 of the following criteria:
- •Serum IgG < 3.5 g/dL
- •Serum IgA < 2.0 g/dL
- •Urine M-protein (kappa or lambda) < 1.0 g/24 hours
- •No lytic lesions on skeletal survey other than a single lesion associated with solitary plasmacytoma within the past 4 weeks
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Zubrod 0-2
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hemoglobin ≥ 10 g/dL* AND/OR
- •No hemoglobin 2 g/dL < lower limit of normal* (LLN) NOTE: *Patients with a history of hemoglobin < 10 g/dL AND/OR < 2 g/dL < LLN that has corrected or improved after epoetin alfa but requires continued treatment with epoetin alfa are not eligible
- •Not specified
- •Calcium ≤ 10.5 mg/dL OR
- •Calcium normal
- •Creatinine ≤ 2 mg/dL
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or stage I or II cancer that is currently in complete remission
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •No prior high-dose steroids except to relieve neurological compromise
- •Radiotherapy
- •Prior localized radiotherapy for myeloma allowed
- •Concurrent radiotherapy allowed
- •Prior surgery for myeloma allowed
- •No other prior therapy for myeloma
- •Concurrent enrollment in protocol SWOG-S0309 (Myeloma Specimen Repository) allowed
排除标准
- 未提供
研究组 & 干预措施
MRI and PET
Magnetic resonance imaging and positron emission tomography
干预措施: magnetic resonance imaging (Procedure)
MRI and PET
Magnetic resonance imaging and positron emission tomography
干预措施: positron emission tomography (Procedure)
结局指标
主要结局
proportion of patients misclassified as solitary plasmacytoma
时间窗: 2 months
次要结局
未报告次要终点