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

18 Years
70 Years
Open (Enrolling by invite only)
Breast Cancer, Neoadjuvant Therapy

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Trial Information

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.

Inclusion Criteria:

- Participant is willing and able to give informed consent for participation in the

- 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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

The ratio of average stiffness measured within the tumour over average stiffness measured in the stroma

Outcome Description:

Tissue stiffness will be used to assess a patients response to chemotherapy

Outcome Time Frame:

Patients will be followed over the course of chemotherapy treatment, an expected average of 18 weeks

Safety Issue:


Principal Investigator

Ruth English, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oxford University NHS Trust


United Kingdom: National Health Service

Study ID:




Start Date:

February 2012

Completion Date:

February 2013

Related Keywords:

  • Breast Cancer
  • Neoadjuvant Therapy
  • Breast Neoplasms