NCT00589537Unknown3 期
Trial of Imaging and Schedule in Seminoma Testis
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 660
- 试验地点
- 58
- 主要终点
- Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease
研究概览
简要总结
RATIONALE: Imaging procedures, such as MRI and CT scan, may find recurrent cancer. It is not yet known which MRI or CT scan schedule is more effective in finding recurrent cancer.
PURPOSE: This randomized phase III trial is comparing four different MRI and CT scan schedules in patients with stage I seminoma of the testicle.
详细描述
OBJECTIVES:
- To assess whether a reduced computed tomography (CT) schedule or magnetic resonance imaging (MRI) could be used as safe and effective alternatives to standard CT-based surveillance in the management of patients with stage I seminoma of the testis.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 surveillance arms.
- Arm I: Patients undergo computed tomography (CT) scan of the abdomen/retroperitoneum* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression.
- Arm II: Patients undergo CT scan of the abdomen/retroperitoneum* at 6, 18, and 36 months in the absence of disease progression.
- Arm III: Patients undergo magnetic resonance imaging (MRI) of the abdomen/retroperitoneum* at 6, 12, 18, 24, 36, 48, and 60 months in the absence of disease progression.
- Arm IV: Patients undergo MRI of the abdomen/retroperitoneum* at 6, 18, and 36 months in the absence of disease progression.
NOTE: *Patients with a history of ipsilateral inguino-scrotal surgery also undergo imaging of the pelvis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of patients relapsing with Royal Marsden Hospital stage IIC or greater disease
次要结局
- Difference in mean abdominal mass size at relapse between computed tomography (CT) scan and magnetic resonance imaging (MRI)
- Time on surveillance before detection of relapse
- Prospective identification of first modality to detect relapse (patient symptom, clinical examination, tumor marker, chest x-ray, cross-sectional image)
- Extent of relapse according to International Germ Cell Cancer Collaborative Group classification
- Disease-free survival
- Overall survival
- Prospective evaluation of prognostic factors for relapse
- Number of false positive MRIs
- Resource use and costs
研究者
研究点 (58)
Loading locations...
相似试验
已完成
3 期
Trial of Imaging and Schedule in Seminoma TestisTesticular cancerCancerISRCTN65987321Medical Research Council (UK)669
已完成
不适用
Diagnostic Study of Patients With Stage I Testicular CancerTesticular Germ Cell TumorNCT00003800Eastern Cooperative Oncology Group76
招募中
不适用
Diagnostic Value of MRI-targeted Plus Index-lesion-ipsilaterally Systematic Biopsy for Biopsy-naive Men At Risk of Prostate CancerProstate CancerNCT06584279The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School563
招募中
不适用
Performance of Prostate MRI and Following Biopsy to Detect Prostate Cancer Recurrence After Focal TherapyProstate CancerNCT04773821Assistance Publique - Hôpitaux de Paris260
已完成
不适用
Detecting local recurrent prostate cancer: MRI:patterns of post-prostatectomy recurrence and of its response to salvege radiotherapy using Enhanced and Dynamic Contrast Enhanced (DCE) MRIC61Malignant neoplasm of prostateDRKS00003469niversitätsklinikum Freiburg, Klinik für Strahlenheilkunde33