2023-508591-11-00招募中3 期
FDG-PET/CT versus conventional CT for response monitoring in metastatic breast cancer: a multicenter randomized clinical trial (MONITOR-RCT)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 11
- 主要终点
- Overall survival
研究概览
简要总结
The primary objective of the MONITOR-RCT is to demonstrate that in patients with MBC, response monitoring based on FDG-PET/CT is superior to response monitoring based on CT with respect to overall survival. The objective will be based on applying standardized response evaluation criteria, using an appropriate adaptation of the PERCIST criteria for FDG-PET/CT and the RECIST1.1 criteria for CT.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Women and men aged≥18 years
- •Diagnosis of distant relapsed MBC (biopsy-verified) or de novo breast cancer. In patients with distant relapsed MBC, biopsy verification from a distant metastasis is required. In patients with de novo MBC, biopsy verification of primary tumor and diagnostic imaging with distant metastasis with a typical pattern of MBC is required.
- •Considered eligible for first-line systemic treatment
- •Considered eligible for continuous treatment monitoring by scans
- •Signed informed consent
- •Participants must have the ability to read and understand the following languages based on their country of participation: in Denmark, patients must be able to read and understand Danish; in Italy, they must be able to read and understand Italian or English; and in Germany, they must be able to read and understand German or English.
排除标准
- •Pregnant or lactating women
- •Ongoing oncological treatment for another cancer
- •Exclusively brain metastasis
- •Allergy to FDG
结局指标
主要结局
Overall survival
Overall survival
次要结局
- Quality of life
- Time and exposure to oncologic treatment
- Cost-effectiveness
研究者
Malene Grubbe Hildebrandt
Scientific
Odense University Hospital
研究点 (11)
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