A Study to Correlate Ultrasound Elastography With Histopathology to Monitor the Response of Locally Advanced Breast Cancer to Neoadjuvant Chemotherapy
NCT ID: NCT01737970
Last Updated: 2017-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
10 participants
OBSERVATIONAL
2012-02-29
2014-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Oxford
OTHER
Oxford University Hospitals NHS Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ruth English, M.D.
Role: PRINCIPAL_INVESTIGATOR
Oxford University NHS Trust
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
12/SC/0170
Identifier Type: -
Identifier Source: org_study_id