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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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England
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Hull、England、イギリス、HU3 2KZ
- Cactus Clinical Trials Unit
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
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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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協力者と研究者
捜査官
- 主任研究者：Lindsay W. Turnbull, MD、Hull Royal Infirmary
研究記録日
主要日程の研究
研究開始
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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