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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. oktober 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

10

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The ratio of average stiffness measured within the tumour over average stiffness measured in the stroma
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2012

Primær fullføring (Faktiske)

1. juli 2014

Studiet fullført (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først innsendt

20. november 2012

Først innsendt som oppfylte QC-kriteriene

29. november 2012

Først lagt ut (Anslag)

30. november 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. oktober 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. oktober 2017

Sist bekreftet

1. oktober 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 12/SC/0170

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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