MRI in Predicting Early Response to Chemotherapy in Patients With Locally Advanced Breast Cancer
Neo Comice Pilot; Efficacy of Advanced Semi-automated Functional Magnetic Resonance (MR) Imaging in the Early Prediction of Response of Locally Advanced Breast Cancer to Neoadjuvant Chemotherapy
RATIONALE: Diagnostic procedures such as MRI scans may help predict early response to treatment in patients with breast cancer undergoing chemotherapy.
PURPOSE: This phase II trial is studying MRI in predicting early response to chemotherapy in patients with locally advanced breast cancer.
研究概览
详细说明
OBJECTIVES:
- To determine the technical feasibility of using MRI in a multicenter setting using the most commonly available magnetic resonance (MR) systems (i.e., is the trial able to scan patients to a specific protocol, using different types of MRI machine) measured by the number of MRI scans not completed to technical specifications (i.e., incorrect sequences or incomplete scans) or trial protocol (i.e., scans not completed or completed at the wrong time).
- To determine how reliably the imaging data can be analyzed in a centralized, semi-automated manner (i.e., can MRI data be reliably transferred from different centers and analyzed using software based in the center for MR investigations at the University of Hull) measured by the number of cases where automated data analysis of completed MRI scans was not possible (i.e., data could not be analyzed at all or data required manual analysis).
OUTLINE: This is a multicenter study.
Patients undergo magnetic resonance imaging (MRI) scans at baseline, 4-7 days after beginning after the first course of chemotherapy, at the end of their second course of chemotherapy, and at the end of their fourth course of chemotherapy (first regimen). MRI techniques may include dynamic contrast-enhanced, diffusion-weighted, and spectroscopic.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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England
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Hull、England、英国、HU3 2KZ
- Cactus Clinical Trials Unit
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Newly diagnosed, histologically proven breast cancer
- Stage T2-4B, N0-3C, and M0 disease
- Locally advanced primary disease
- Underwent both x-ray mammography and breast ultrasound scanning during the current treatment episode
- Scheduled for neoadjuvant chemotherapy
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Medically stable
- No renal failure
- No serious breast trauma within the past 3 months
- No known allergic reaction associated with previous administration of a paramagnetic contrast agent
No known contraindication to magnetic resonance (MR) scanning
- Must pass the normal safety requirements of MR, particularly pacemakers and cardiac defibrillators
- No disability preventing MR scanning in the prone position
- No body habitus incompatible with MR system entry
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy
No prior surgery or radiotherapy for cancer in the ipsilateral breast
- More than 4 months since prior surgery to the ipsilateral breast for benign breast disease
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
研究衡量的是什么？
主要结果指标
结果测量 |
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Failed scan rate (i.e., the number of scans that failed protocol) grouped by cause, including patient refusal, protocol violation in timing, major errors in scan protocols, and minor errors in scan protocol
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Failed automated MRI-scan data-analysis rate (i.e., number of scans that required manual reading and number of protocol-compliant scans that were unreadable, subdivided according to whether the scans were technically compliant or not)
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合作者和调查者
调查人员
- 首席研究员：Lindsay W. Turnbull, MD、Hull Royal Infirmary
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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