Functional Imaging in the Assessment of mRCC Response to Sunitinib
Pilot Study to Evaluate the Feasibility of Functional MRI in Metastatic Renal Cell Carcinoma (mRCC) With Test--retest Repeatability and Early Response Assessment
調査の概要
詳細な説明
Renal cell carcinoma (RCC) is a highly vascularized tumour that is dependent on new vessel formation (angiogenesis) for growth and spread beyond the kidney (metastases). In recent years a new class of drugs have been developed which target the formation of this blood supply, stopping tumour growth and resulting in increased survival. These anti-angiogenic drugs such as Sunitinib, Pazopanib, Axitinib and Everolimus are now the standard of care in metastatic RCC (mRCC) in the United Kingdom.
Currently we assess if cancers are responding to treatment by looking at changes in the size of the tumour and metastases using computed tomography. However, the positive effects of drugs such as sunitinib do not always show a change in size, particularly early in treatment. Therefore we need to develop alternative methods for assessing if patients are responding in order to optimise individual management plans and prevent unnecessary toxicity and cost.
The aim of this study is to assess if three different functional magnetic resonance imaging (MRI) techniques are able to predict which patients will derive benefit from anti-angiogenic therapy early in their treatment. The study will recruit patients with mRCC who are going to be treated with anti-angiogenic drugs. These patients will have an MRI scan before they commence treatment and then a further scan after one treatment cycle (4 weeks) in addition to their normal clinical follow-up. The sequences being evaluated (arterial spin labeling, diffusion-weighted imaging and dynamic contrast imaging) look at the blood supply to the cancer and it is expected that there will be different changes in this blood supply in patients who are benefiting from treatment compared to those who are not responding. Early knowledge of response will help doctors choose the most appropriate treatment option for each individual patient.
Consenting patients with treatment naïve metastatic clear cell RCC will be recruited to the study. Before commencing anti-angiogenic therapy, patients will undergo 3 Tesla MRI covering the primary tumour or largest metastatic deposit identified from their staging CT examination if prior nephrectomy has been performed. Following 4 weeks of therapy (one treatment cycle), patients will undergo repeat MR imaging using the same protocol.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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London、イギリス
- Imperial College Healthcare NHS Trust
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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
Inclusion Criteria:
- Patients with newly diagnosed (i.e. treatment naive) metastatic clear cell renal cell carcinoma judged by their treating physician to have the potential to derive benefit from anti-angiogenic therapy
- Histopathologically confirmed clear cell renal cell carcinoma
- Male or female aged 18 years or older
Exclusion Criteria:
- Previous medical treatment for renal cancer
- Cardiac pacemaker or other contra-indication to magnetic resonance imaging
- Contra-indication to intravenous Gadolinium
- Pregnancy or breastfeeding
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
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Metastatic renal cell carcinoma
Patients with clear cell renal cell carcinoma treated with anti-angiogenic therapies
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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 |
時間枠 |
|---|---|
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To determine if functional MRI techniques are able to detect treatment-related changes in patients with metastatic renal cell carcinoma treated with sunitinib
時間枠:At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
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At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Repeatability of Arterial Spin Label and Diffusion Weighted MRI parameters
時間枠:At baseline MRI scan
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At baseline MRI scan
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Changes in imaging parameters with treatment
時間枠:At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
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At baseline and following one treatment cycle (expected 4 weeks) with anti-angiogenic therapy
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Correlation of imaging parameters with progression free survival
時間枠:Time from study enrolment to progression assessed by RECIST v1.1 on computed tomography performed after every three treatment cycles (up to 36 months)
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Time from study enrolment to progression assessed by RECIST v1.1 on computed tomography performed after every three treatment cycles (up to 36 months)
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Correlation of imaging parameters with overall survival
時間枠:Time from study enrolment to date of death from any cause (up to 36 months)
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Time from study enrolment to date of death from any cause (up to 36 months)
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協力者と研究者
捜査官
- 主任研究者:Nishat Bharwani, MRCP FRCR、Imperial College Healthcare NHS Trust
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
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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