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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01737970
Enrollment
10
Registered
2012-11-30
Start date
2012-02-29
Completion date
2014-07-31
Last updated
2017-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Neoadjuvant Therapy

Brief summary

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.

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.

Interventions

None listed

Sponsors

University of Oxford
CollaboratorOTHER
Oxford University Hospitals NHS Trust
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The ratio of average stiffness measured within the tumour over average stiffness measured in the stromaPatients will be followed over the course of chemotherapy treatment, an expected average of 18 weeksTissue stiffness will be used to assess a patients response to chemotherapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026