A Pilot Study Using Magnetic Resonance (MR) to Assess Cervix Motion During Radiotherapy Treatment. (MR Cervix)
The standard treatment for locally advanced cervical cancer is concurrent chemo-radiotherapy. This treatment is associated with long term side effects in around half of patients with up to 10% suffering from grade 3-4 toxicity.
The development of intensity modulated radiotherapy (IMRT) allows for shaping of radiotherapy fields to reduce the doses delivered to organs at risk (OARs). This does appear to reduce the risk of long and short term toxicity (although there is little randomized evidence). However pelvic organ position varies both between and even during radiotherapy fractions; this means that radiotherapy margins must be generous to allow adequate coverage of the clinical target volume (CTV) but this also increases dose to OARs.
There have been a number of studies evaluating pelvic organ motion in cervical cancer as well as assessing different adaptive radiotherapy strategies. These have included individualized margins, plan of the day and adaptive techniques. Most of these studies have been carried out using cone beam computed tomography (CBCT) imaging which is often poor quality with limited soft tissue contrast. MR offers better visualization of the tumour and OARs and is used for imaged guided brachytherapy treatment.
This study will explore the role of MR imaging in adaptive radiotherapy for cervical cancer with development of a number of theoretical treatment strategies.
調査の概要
詳細な説明
Patients will undergo standard treatment during the study with five weeks of external beam radiotherapy (25 fractions) followed by a MR guided brachytherapy boost or external beam boost (further 10 fractions.) They will be treated with weekly cisplatin 40mg/m2 if clinically appropriate.
As part of standard treatment patients have a staging MR scan at diagnosis, a radiotherapy planning CT and an MR scan in the 4th week of treatment. Cone beam imaging will also be performed. Response will be assessed as standard with a MR scan at 3 months.
As part of the study patients will undergo 3 additional MR scans. These will take place in the 1st, 2nd and 5th weeks of treatment. Extra sequences will be added to the clinical mid-point scan in the 4th week of treatment. These MR scans will include anatomical images - with full and empty bladder as well as cine data (with a scan every minute for 10 minutes) to assess intra fraction motion. They will also include a DWI sequence, which will be used to assess if early prediction of response is possible. The frequency of cone beam imaging will be increased from approximately 10 scans as standard of care to 25 scans to allow for daily imaging.
The 1st MR scan will be contoured to outline clinical target volumes (CTVs) and OARs. A variety of planning strategies will be developed including standard planning target volume (PTV) margins, a plan of the day (POTD) approach, a POTD+ as well as an online adaptation model. These models will be used to assess coverage of CTV and PTV as well as dose to OARs using the scans obtained during the radiotherapy treatment. The practicality of each approach will also be assessed. Inter and intra fraction organ motion will also be analysed in order to develop patient specific models.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Greater Manchester
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Manchester、Greater Manchester、イギリス、M20 4BX
- The Christie NHS Foundation Trust
-
-
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:
- Histologically confirmed diagnosis of cervical cancer
- Treatment with primary curative intent
- Undergoing external beam radiotherapy (+/-chemotherapy) followed by brachytherapy or an external beam boost
- Age over 18
Exclusion Criteria:
- Any contraindications to MR identified after MR safety screening including completion of an MR Safety Screening Form (see appendix 1)
- Previous hysterectomy
- Unable to tolerate MR scans
- Metastatic disease
- Pregnancy
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：基礎科学
- 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 |
|---|---|
|
実験的：MR scans
As part of the study patients will undergo 3 additional MR scans during radiotherapy treatment.
These will take place in the 1st, 2nd and 5th weeks of treatment.
|
Additional imaging using MR scans.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Coverage of the Clinical Target Volume and dose to the Organs At Risk for different adaptive radiotherapy strategies.
時間枠：18 months
|
Coverage of the Clinical Target Volume and dose to the Organs At Risk for different adaptive radiotherapy strategies.
|
18 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diffusion Weighted Imaging on MR prior to and during treatment and clinical response to treatment on post treatment MR scan.
時間枠：18 months
|
Diffusion Weighted Imaging on MR prior to and during treatment and clinical response to treatment on post treatment MR scan.
|
18 months
|
|
Bladder filling using MR sequences and stratification of patients into large or small cervix motion.
時間枠：18 months
|
Bladder filling using MR sequences and stratification of patients into large or small cervix motion.
|
18 months
|
協力者と研究者
捜査官
- 主任研究者：Marcel van Herk、University of Manchester
- 主任研究者：Ananya Choudhury、The Christie NHS Foundation Trust
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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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