SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in patient management decision
研究概览
简要总结
This trial studies how well technetium Tc-99m sestamibi single-photon emission computed tomography/computed tomography (SPECT/CT) works on clinical decision making in patients with kidney tumors. Diagnostic procedures, such as technetium Tc-99m sestamibi SPECT/CT may be a less invasive way to check for kidney tumors.
详细描述
PRIMARY OBJECTIVES:
I. To determine the impact of technetium Tc-99m sestamibi (MIBI) SPECT/CT on patient management decisions.
SECONDARY OBJECTIVES:
I. To evaluate the impact of MIBI SPECT/CT on patient management decisions for tumors 1.5-3.0 cm and 3.1-5.0 cm.
II. To assess the impact of MIBI SPECT/CT on decisional conflict score. III. To assess the impact of MIBI SPECT/CT on physician management recommendation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Performance status Eastern Cooperative Oncology Group (ECOG) <
- •Life expectancy (> 1 year).
- •New diagnosis of a renal tumor (within past 3 months).
- •Measurable, predominantly (> 80%) solid renal neoplasm between 1.5-5.0 cm.
- •Lesion concerning for kidney cancer bases on a contrast-enhanced CT or magnetic resonance imaging (MRI).
- •No definitive evidence of metastatic disease.
- •Does not require urgent surgical treatment.
- •Candidate for surgical, ablative, and surveillance approach.
- •Willingness to obtain more information to aid decision-making.
- •Understanding and willingness to provide consent.
排除标准
- •Presence of multiple solid renal tumors.
- •A prior needle biopsy of the mass resulting in histologic diagnosis.
- •A prior diagnosis of kidney cancer.
- •Presence of an active, untreated, non-renal malignancy.
- •History of bleeding diathesis or recent bleeding episode.
- •Prior surgery or radiation therapy to the kidney.
- •Unwillingness to fill out questionnaires.
研究组 & 干预措施
Health service research (MIBI SPECT/CT, questionnaire)
Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.
干预措施: Computed Tomography (Procedure)
Health service research (MIBI SPECT/CT, questionnaire)
Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.
干预措施: Questionnaire Administration (Other)
Health service research (MIBI SPECT/CT, questionnaire)
Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.
干预措施: Single Photon Emission Computed Tomography (Procedure)
Health service research (MIBI SPECT/CT, questionnaire)
Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.
干预措施: Technetium Tc-99m Sestamibi (Radiation)
结局指标
主要结局
Change in patient management decision
时间窗: 6 months
Assessed with post-test, physician counseling.
次要结局
- Decision making based on tumor size(6 months)