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 number | NCT00978770 |
| Secondary identifying numbers | Version 1 |
- 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
Contact information
Prof Lindsay Turnbull
Scientific
Scientific
Centre for MR Investigations
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Study information
| Study design | Phase II multicentre prospective longitudinal observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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) |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/06/2009 |
| Completion date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
United Kingdom
Sponsor information
Hull and East Yorkshire NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
R&D Manager
Second Floor
Daisy Building
Castle Hill Hospital
Cottingham
Hull
HU16 5JQ
England
United Kingdom
| Website | http://www.hey.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01b11x021 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (grant ref: C11421/A9398)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| 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.
