Response assessment in head & neck cancer using multi-parametric Magnetic Resonance Imaging (MRI)

ISRCTN	ISRCTN58327080
DOI	https://doi.org/10.1186/ISRCTN58327080
Secondary identifying numbers	1.3

Submission date: 12/01/2014
Registration date: 10/02/2014
Last edited: 15/05/2023

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-using-different-scans-to-see-how-well-treatment-works-for-head-and-neck-cancer

Contact information

Dr Stephen Connor
Scientific

Neuroradiology Department
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Study information

Study design	Prospective cohort observational study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please contact adrian.green@gstt.nhs.uk to request a patient information sheet
Scientific title	The accuracy of quantitative diffusion weighted MRI and 18F-FDG PET-CT in the prediction of locoregional residual disease following radiotherapy and chemoradiotherapy for head and neck cancer
Study objectives	It is hypothesized that residual areas of active disease may manifest as areas of lower ADC (restriction) or greater heterogeneity. The addition of diffusion weighted MRI and post processing techniques to quantify diffusion (ADC), may thus improve the accuracy of imaging in detecting residual cancer post treatment.
Ethics approval(s)	NRES Ethics Board: London Camberwell St Giles, 13/12/013, REC ref 13/LO/1876
Health condition(s) or problem(s) studied	Head and neck cancer
Intervention	Patients will undergo MRI including diffusion-weighted MRI before treatment and at 6 and 12 weeks after completion of radiotherapy (RT) or chemoradiotherapy. Patients will undergo 18F-FDG PET-CT imaging at 12 weeks after completion of RT or chemoradiotherapy as per institutional protocol. In addition to the standard 1.5 tesla MRI (using a surface phased array neck coil with T1w pre and post gadolinium/T1w fat sat post gadolinium and T2w axial, T1 fat saturated post gadolinium coronal and STIR coronal), a research DWI sequence will be added (matched images in the axial plane with multiple b values to enable assessment of the perfusive and diffusive fraction. Further image analysis will be performed offline (Oncotreat, Siemens Healthcare, Erlangen, Germany). This will be both qualitative (presence/absence of hyperintensity relative to muscle), and quantitative (ADC0-1000 ADC0-150, ADC500-1000, ADChistogram, ); for the tumour volume of interest. This will be assessed for the primary tumour and pathological (on the basis of standard staging criteria) nodal disease. ROIs will be delineated for the whole tumour volume and for ROIs that avoid areas of necrosis, where possible. Image processing will be performed on the acquired baseline and post treatment MRI and PET images using statistical and model based methods to assess for first and second order texture features. This will be performed using proprietary software developed in-house (FAST, KCL) to calculate exploratory measures including MGLI, skewness, kurtosis, SDH, run length matrix, uniformity, entropy and fractal dimension. The 18F-FDG PET-CT scan will be performed as per standard clinical practice: Patients are fasted for at least 6 hours prior to administration of 350-400MBq 18F-FDG. PET-CT scans are acquired 90 minutes after injection from the upper thigh to the base of skull on one of two scanners (GE, Discovery VCT or DST). Images are reconstructed using OSEM with a reconstructed slice thickness of 3.27mm and pixel size of 5mm. The CT component of the scans is acquired for the same anatomical coverage without administration of oral or intravenous contrast agent for anatomical co-localisation. Pathological evaluation, where available, will be obtained as per usual institutional practice. No additional biopsy will be required as part of the study. Consensus review of clinical and imaging findings (including interval CT and ultrasound imaging) will be performed at 24 months post treatment for all patients.
Intervention type	Other
Primary outcome measure	To compare quantitative DW-MRI with18F-FDG PET-CT in the prediction of locoregional residual disease following primary chemoradiotherapy or radiotherapy for stage 3 and 4 head and neck cancer
Secondary outcome measures	1.To assess whether different methods of calculating ADC (e.g. ADCperfusion, ADCdiffusion), and different methods of acquiring diffusion data can improve the prediction of residual disease 2. To assess if baseline ADC and changes in ADC from baseline to post treatment can improve prediction of residual disease 3. To determine if texture analysis, a post processing imaging technique, of acquired PET and MRI images to measure tumour heterogeneity can improve the prediction of residual disease 4. To compare DW-MRI parameters with standard structural MRI assessment for the prediction of residual disease 5. To correlate the quantitative MRI and PET-CT with locoregional progression-free survival (LPFS), disease-free survival (DFS) and overall survival (OS) 6. To determine if texture analysis (a post processing imaging technique of acquired standard and research MRI images to measure tumour heterogeneity) can improve the prediction of residual disease
Overall study start date	01/04/2014
Completion date	01/01/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	50
Total final enrolment	65
Key inclusion criteria	1. Male or female, 18 years age or older 2. Stage 3 or 4 primary squamous cell carcinoma of the head and neck 3. One centimetre measurable area of primary or nodal tumour on the basis of standard clinico-radiological staging Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 4. The capacity to understand the patient information sheet and the ability to provide written informed consent see summary 5. Treatment with curative intent 6. Histologically confirmed squamous cell carcinoma
Key exclusion criteria	1. Standard contraindications to MRI and positron emission tomography computerised tomography (PET-CT) 2. Known allergy to Gadolinium contrast 3. Calculated glomerular filtration rate (GFR) (Cockroft or EDTA) < 30 mls/min 4. Prior chemotherapy or radiotherapy 5. Distant metastatic disease
Date of first enrolment	01/04/2014
Date of final enrolment	01/04/2018

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

King's College Hospital

London
SE5 9RS
United Kingdom

Sponsor information

King's College Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

161 Denmark Hill
London
SE5 9RS
England
United Kingdom

Phone	+44 (0)20 3299 1980
Email	kch-tr.research@nhs.net
"ROR"	https://ror.org/01n0k5m85

Funders

Funder type

Charity

Guy's and St Thomas' Charity
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
Location: United Kingdom

Results and Publications

Intention to publish date	01/01/2021
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal. There are likely to be several publications.
IPD sharing plan

Study outputs

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	07/05/2021	10/05/2021	Yes	No
Plain English results		15/05/2023	No	Yes
HRA research summary		28/06/2023	No	No

Editorial Notes

15/05/2023: A link to plain English results was added.
10/05/2021: Publication reference added.
01/02/2021: The total final enrolment number has been added.
16/03/2020: Internal review.
04/04/2019: The overall trial end date was changed from 01/04/2018 to 01/01/2020. Publication and dissemination plan added.