Assessing Treatment Response in Breast Cancer With Functional Imaging

NCT02688257 | Completed

• 1 other identifier: 10/H0806/50 CCR3372
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with large primary operable breast cancers are offered chemotherapy prior to surgery to shrink the tumour and enable breast conserving surgery. Conventional assessment of response to chemotherapy relies on a change in tumour size which does not always correlate with the change in amount of viable tumour. Newer techniques such as functional MRI, microbubble and optoacoustic ultrasound offer the potential to detect responses to chemotherapy by evaluating functional changes in tumour vascularity and oxygenation. Neither modality utilises ionising radiation. Although MRI is widely used for detecting breast cancer, its ability in assessing functional responses to chemotherapy prior to surgery has not been fully exploited. Dynamic contrast enhanced (DCE) MRI has a sensitivity around 90% and provides quantitative measurements of blood volume and flow. Other functional techniques detect variation in tissue oxygenation: this is called the blood oxygen level-dependent (BOLD) mechanism. The BOLD technique uses a special magnetic resonance (MR) sequence called T2\* to measure the weakly magnetic effect of deoxygenated haemoglobin. The investigators wish to develop and validate T2\* measurements which relate to oxygenation of a tumour. The investigators also want to validate other MR sequences including diffusion weighted (DW) MRI, which quantifies microcirculation of blood in the capillary network and the diffusion of water within tissues. Microbubble ultrasound is an established technique that utilises an intravenous contrast agent comprising tiny microbubbles of gas that can increase the reflectivity of blood and enhance spectral and colour Doppler signals obtained from routine ultrasound imaging. Optoacoustic imaging is new technique where the output signal depends on the oxygenation of the tissues under study. It utilises a light signal input and measures ultrasound signal output. The investigators want to correlate our imaging findings with histopathology after surgical resection of the tumour.

Conditions

Breast Cancer

Keywords

Magnetic Resonance Imaging; Ultrasound; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Early and late changes of oxygenation and residual cellularity of patients treated with neoadjuvant chemotherapy, measured using the blood oxygen level dependent (BOLD) technique.

  The primary aim of the study is to determine whether specific MRI sequences including dynamic contrast enhanced (DCE) MRI, T2\*, diffusion weighted (DW) MRI, as well as microbubble and optoacoustic ultrasound imaging provide early measures of treatment response in breast tumours treated with neoadjuvant chemotherapy.

  6 years

Interventions

MRI OTHER

Functional magnetic resonance imaging

Ultrasound OTHER

Optoacoustic imaging

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with breast cancer who are due for neoadjuvant chemotherapy

You may qualify if:

• Patients with breast cancer due for neoadjuvant chemotherapy

You may not qualify if:

• Ferromagnetic implants within body in accordance with standard clinical practice
• claustrophobia
• age \<18 or \>90

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Cancer Research UK: collaborator

Study Sites (1)

The Institute of Cancer Research and Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Nandita DeSouza

  ICR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Nandita DeSouza

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 23, 2016
• Study Start: September 1, 2010
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

GB (1)