Multi-Modality Detection of RCC Recurrence Post Ablation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Renal cell carcinoma recurrence
研究概览
简要总结
This phase II trial studies how well contrast-enhanced ultrasound (CEUS) works for diagnosing patients with renal cell cancer (RCC) that has come back (recurrent) after an ablation. Diagnostic imaging, such as CEUS, may help find and monitor long term renal cell cancer recurrence following cryo or microwave ablation.
详细描述
PRIMARY OBJECTIVE:
I. To characterize and compare the sensitivity, specificity, positive and negative predictive value, and inter-reader agreement of 2D contrast-enhanced ultrasound (CEUS) and contrast-enhanced computed tomography (CT)/magnetic resonance imaging (MRI) for detecting recurrent or residual renal cell carcinoma (RCC) following ablation, using a combination of standard of care imaging follow-up and tissue pathology as a reference standard.
SECONDARY OBJECTIVES:
I. To evaluate the potential improvement to the qualitative assessments of 2D CEUS when fused with the patient's pre-treatment cross sectional imaging.
II. To assess the potential added value of using multi-modality volumetric CEUS for detecting RCC recurrence post ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Previously received cryotherapy or microwave therapy of RCC
- •Has available contrast enhanced (CE)-MRI or CE-CT imaging prior to ablative therapy
- •Have previously had or are scheduled to have a contrast-enhanced MRI/CT for the monitoring of RCC recurrence within 4 weeks of the CEUS study
- •Be at least 18 years of age
- •Be medically stable
- •If a female of child-bearing age, must have a negative pregnancy test
- •Have signed Informed Consent to participate in the study
排除标准
- •Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable
- •Patients with known sensitivities to the components of Lumason
研究组 & 干预措施
Diagnostic (CEUS with MRI/CT)
Patients receive Lumason IV and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study.
干预措施: Sulfur Hexafluoride Lipid Microspheres (Drug)
Diagnostic (CEUS with MRI/CT)
Patients receive Lumason IV and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study.
干预措施: Contrast-Enhanced Ultrasound (Procedure)
Diagnostic (CEUS with MRI/CT)
Patients receive Lumason IV and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study.
干预措施: Computed Tomography (Procedure)
Diagnostic (CEUS with MRI/CT)
Patients receive Lumason IV and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic (CEUS with MRI/CT)
Patients receive Lumason IV and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Renal cell carcinoma recurrence
时间窗: Up to 2 years
Baseline imaging will be reviewed and compared to the contrast enhanced imaging to diagnose recurrence.
次要结局
- Improvement of diagnostic imaging using 2D contrast-enhanced ultrasound (CEUS) with magnetic resonance/ computed tomography fusion(Up to 2 years)
- Measurement with multimodality 3D CEUS to improve detection of recurrence(Up to 2 years)
研究者
john eisenbrey
Associate Professor, Radiology
Thomas Jefferson University