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

ISRCTN	ISRCTN42613663
DOI	https://doi.org/10.1186/ISRCTN42613663
ClinicalTrials.gov (NCT)	NCT00978770
Protocol serial number	Version 1
Sponsor	Hull and East Yorkshire NHS Trust (UK)
Funder	Cancer Research UK (CRUK) (UK) (grant ref: C11421/A9398)

Submission date: 09/04/2009
Registration date: 17/06/2009
Last edited: 27/07/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-MRI-scans-during-chemotherapy-before-surgery-for-breast-cancer-neo-comice-pilot-trial

Contact information

Prof Lindsay Turnbull
Scientific

Centre for MR Investigations
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Study information

Primary study design	Observational
Study design	Phase II multicentre prospective longitudinal observational cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Establishing the efficacy of advanced semi-automated functional magnetic resonance (MR) imaging in the early prediction of response of locally advanced breast cancer to neoadjuvant chemotherapy: a pilot study
Study acronym	Neo-COMICE
Study objectives	This proposal aims to evaluate quantitative functional magnetic resonance imaging (MRI) as an early in-vivo surrogate biomarker. Chemotherapy either directly or indirectly results in a reduction in tumour vascularity and as a consequence quantitative analysis of dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) should be predictive of response to neoadjuvant chemotherapy (NAC) and should not be treatment specific. It is essential that functional MR is compared with other markers of treatment response, namely molecular diagnostic pathology, to enable integration and potential identification of additional prognostic and predictive indicators, and this comparison will be included in a full trial that would follow this feasibility study. It is anticipated that a subsequent multicentre trial will require around 1300 patients using standardised scan protocols and analytical techniques to provide the statistical robustness that will allow the demonstration of statistical significant changes. In preparation for such a multicentre approach, this feasibility study will use multi-parameter, easily deliverable, protocols applicable to all MR manufacturers; to ensure system stability using phantoms; evaluate the logistics of data transfer and compatibility with study software (MATLAB platform); and analyse data off-line using semi-automated segmentation techniques including Otsu's algorithm, iterative thresholding processes, edge detection and active contouring in order to extract tumour volume, and functional and textural parameters. Quality assurance of tumour volume determination will be performed using manual contouring as the gold standard. Use of semi-automated techniques for large volume MR data analysis have already been implemented to good effect using Otsu's algorithm and other iterative techniques for delineating bone trabeculations, obtaining grey-white matter segmentation and breast lesion classification. The applicability of these techniques to breast tumour analysis by MR has been reported and critically reviewed. The main study will require some 1300 patients, recruited from at least 60 centres, using different MRI systems, with the data being analysed centrally using semi-automated techniques. Prior to commencing the main study, the Neo-COMICE pilot study needs to be completed to test the technical feasibility of the main study, i.e. can we reliably, in a multicentre setting using different types of MRI systems, complete MRI scans to protocol, and analyse these centrally using semi-automated techniques? This pilot study will prospectively recruit 50 patients from different centres, using the most commonly available MR systems for data acquisition, and analyse this data using centralised semi-automated techniques. This will test the technical achievability of producing multi-parameter, multi-MR system standardised protocols, ensuring the compatibility of DICOM (Digital Imaging and Communications in Medicine) information between MR manufacturers and the use of semi-automated tumour segmentation and analysis tools for data extraction. These quality-assured findings will be used to further develop the MR imaging protocol and inform the subsequent full trial application.
Ethics approval(s)	Northern and Yorkshire Research Ethics Committee on 02/02/2009 (ref: 08/H0903/73)
Health condition(s) or problem(s) studied	Breast cancer
Intervention	The trial is anticipated to have an active recruitment period of 14 months. Patients will receive MRI scans at baseline (pre-commencement of chemotherapy), 4 - 7 days after commencement of their first cycle of chemotherapy, at the end of their second cycle of chemotherapy, and at the end of their fourth cycle of chemotherapy. The only follow up data that will be routinely collected is the patients' final pathology report if the patient subsequently undergoes surgery.
Intervention type	Other
Primary outcome measure(s)	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) 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)
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	50
Total final enrolment	52
Key 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
Key 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
Date of first enrolment	01/06/2009
Date of final enrolment	01/11/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Hull Royal Infirmary

Hull
HU3 2JZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			27/07/2022	No	Yes

Editorial Notes

27/07/2022: Cancer Research UK plain English results summary link and total final enrolment added.
28/02/2019: No publications found. Verifying results with principal investigator.