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

11. října 2017 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

10

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 70 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The ratio of average stiffness measured within the tumour over average stiffness measured in the stroma
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Spolupracovníci

Vyšetřovatelé

  • Vrchní vyšetřovatel: Ruth English, M.D., Oxford University NHS Trust

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. února 2012

Primární dokončení (Aktuální)

1. července 2014

Dokončení studie (Aktuální)

1. července 2014

Termíny zápisu do studia

První předloženo

20. listopadu 2012

První předloženo, které splnilo kritéria kontroly kvality

29. listopadu 2012

První zveřejněno (Odhad)

30. listopadu 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. října 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. října 2017

Naposledy ověřeno

1. října 2017

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 12/SC/0170

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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