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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737970
First Posted: November 30, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Oxford University Hospitals NHS Trust
  Purpose

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.


Condition
Breast Cancer Neoadjuvant Therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Study to Correlate Ultrasound Elastography With Histopathology to Monitor the Response of Locally Advanced Breast Cancer to Neoadjuvant Chemotherapy.

Resource links provided by NLM:


Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:
  • The ratio of average stiffness measured within the tumour over average stiffness measured in the stroma [ Time Frame: 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


Enrollment: 10
Study Start Date: February 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737970


Sponsors and Collaborators
Oxford University Hospitals NHS Trust
University of Oxford
Investigators
Principal Investigator: Ruth English, M.D. Oxford University NHS Trust
  More Information

Responsible Party: Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01737970     History of Changes
Other Study ID Numbers: 12/SC/0170
First Submitted: November 20, 2012
First Posted: November 30, 2012
Last Update Posted: October 12, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases