Efficacy of advanced semi-automated functional magnetic resonance (MR) imaging in the early prediction of response of locally advanced breast cancer to neoadjuvant chemotherapy

Phase 2

Completed

• Conditions: Breast cancer; Cancer; Malignant neoplasm of the breast

• Registration Number: ISRCTN42613663
• Lead Sponsor: Hull and East Yorkshire NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-17
• Study Completion: 2010-11-01
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

1. Provide written informed consent
2. Female
3. Aged 18 years or over
4. Newly diagnosed, histologically proven breast cancer (TNM stage T2- T4B, N0-3C, and M0)
5. Undergone both x-ray mammography and breast ultrasound scanning during the current treatment episode
6. Scheduled for neo-adjuvant chemotherapy

Exclusion Criteria

1. Are medically unstable
2. Previously undergone chemotherapy
3. Have had surgery or radiotherapy for cancer in the ipsilateral breast
4. Have had surgery to the ipsilateral breast within the previous 4 months for benign breast disease
5. Have a history of serious breast trauma within the last 3 months
6. Are pregnant or breast feeding
7. Have renal failure
8. Fail the normal safety requirements of MR, particularly pacemakers and cardiac defibrillators
9. Are known to have had an allergic reaction associated with previous administration of a paramagnetic contrast agent
10. Have a known contraindication to MR scanning
11. Have a disability preventing MR scanning in the prone position
12. Have body habitus incompatible with MR system entry

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The technical feasibility of using MR imaging in a multicentre setting using the most commonly available MR systems (i.e. is the trial able to scan patients to a specific protocol, using different types of MRI machine)<br> 2. How reliably the imaging data can be analysed in a centralised, semi-automated, manner (i.e. can MRI data be reliably transferred from different centres and analysed using software based in the Centre for MR Investigations at the University of Hull)<br>

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures