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A Study to Correlate Ultrasound Elastography With Histopathology to Monitor the Response of Locally Advanced Breast Cancer to Neoadjuvant Chemotherapy

2017年10月11日 更新者:Oxford University Hospitals NHS Trust

A Study to Correlate Ultrasound Elastography With Histopathology to Monitor the Response of Locally Advanced Breast Cancer to Neoadjuvant Chemotherapy.

This research proposal concerns a study to monitor the effects of chemotherapy on breast cancer tumour and peritumour stromal cells using ultrasound (US) elastography (also known as strain imaging).

Many cancer treatments currently being developed are targeted; that is they exploit particular biological processes in specific cancer cell types to disrupt tumour growth. Being able to monitor the efficacy of these typically high-cost drug therapies is essential both for the best patient outcome as well as offering economical benefits to the health care system and much needed insight into future drug development.

Ultrasound provides a relatively inexpensive, non-invasive means for imaging cancers, and has been used widely in breast cancer diagnosis for many years. Its role in therapy monitoring has been suggested but has not been well explored. The purpose of this proposal is to explore this potential in more depth.

It has been identified that significant interaction takes place between tumour and stroma through all stages of tumour growth; this complex relationship is an ongoing topic of research. Fibrotic changes occur during tumour growth and are also a quintessential process of healing. Indeed, fibrosis is a common after effect to chemotherapy in many forms of cancer. Elastography is an established imaging technique (based on ultrasound or MRI) which can estimate the relative stiffness of tissues in vivo and is thus well-suited to monitor these particular biological processes.

This elucidates the main hypothesis of this project: fibrosis, cancer cell necrosis and inflammation may all contribute to a measurable response in elastography. These changes to the tissue composition can be imaged over a course of a patient's treatment to assess the response to chemo/hormonal therapy.

The ultimate project goals are to develop a clinical tool (based on ultrasound elastography) to improve treatment management in addition to offering a better biological understanding of tumour/stroma behaviour.

調査の概要

詳細な説明

This research proposal concerns a study to monitor the effects of chemotherapy on breast cancer tumour and peritumour stromal cells using ultrasound (US) elastography (also known as strain imaging).

Many cancer treatments currently being developed are targeted; that is they exploit particular biological processes in specific cancer cell types to disrupt tumour growth. Being able to monitor the efficacy of these typically high-cost drug therapies is essential both for the best patient outcome as well as offering economical benefits to the health care system and much needed insight into future drug development.

Ultrasound provides a relatively inexpensive, non-invasive means for imaging cancers, and has been used widely in breast cancer diagnosis for many years. Its role in therapy monitoring has been suggested but has not been well explored. The purpose of this proposal is to explore this potential in more depth.

It has been identified that significant interaction takes place between tumour and stroma through all stages of tumour growth; this complex relationship is an ongoing topic of research. Fibrotic changes occur during tumour growth and are also a quintessential process of healing. Indeed, fibrosis is a common after effect to chemotherapy in many forms of cancer. Elastography is an established imaging technique (based on ultrasound or MRI) which can estimate the relative stiffness of tissues in vivo and is thus well-suited to monitor these particular biological processes.

This elucidates the main hypothesis of this project: fibrosis, cancer cell necrosis and inflammation may all contribute to a measurable response in elastography. These changes to the tissue composition can be imaged over a course of a patient's treatment to assess the response to chemo/hormonal therapy.

The ultimate project goals are to develop a clinical tool (based on ultrasound elastography) to improve treatment management in addition to offering a better biological understanding of tumour/stroma behaviour.

研究の種類

観察的

入学 (実際)

10

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~70年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Patient will be selected from clinically diagnosed patients with breast cancer undergoing neoadjuvant chemotherapy. These women will be recruited through the Oxford University NHS Trust cancer centre and will consist primarily of women living within Oxfordshire.

説明

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Has an established diagnosis of locally advanced breast cancer.
  • Aged 18 years or above.
  • History of previous breast cancer does not exclude from study.
  • Having neoadjuvant chemotherapy delivered in Oxford Cancer Centre.
  • Good general health
  • Blood tests to check suitability for the diagnostic core biopsy
  • Having a localisation coil as part of routine medical care.
  • Patients who are recruited into other studies can be included if there is no conflict of interest and the patient is in agreement.

Exclusion Criteria:

  • Any co-morbidity that is likely to prevent regular attendance.
  • Is <18 years of age or over 70 years.
  • Has a movement disorder as the patient is required to lie very still for a few minutes during the scan.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

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
The ratio of average stiffness measured within the tumour over average stiffness measured in the stroma
時間枠:Patients will be followed over the course of chemotherapy treatment, an expected average of 18 weeks
Tissue stiffness will be used to assess a patients response to chemotherapy
Patients will be followed over the course of chemotherapy treatment, an expected average of 18 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Ruth English, M.D.、Oxford University NHS Trust

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2012年2月1日

一次修了 (実際)

2014年7月1日

研究の完了 (実際)

2014年7月1日

試験登録日

最初に提出

2012年11月20日

QC基準を満たした最初の提出物

2012年11月29日

最初の投稿 (見積もり)

2012年11月30日

学習記録の更新

投稿された最後の更新 (実際)

2017年10月12日

QC基準を満たした最後の更新が送信されました

2017年10月11日

最終確認日

2017年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 12/SC/0170

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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