Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.3
Study information
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
Acronym
Study hypothesis
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
NRES Ethics Board: London Camberwell St Giles, 13/12/013, REC ref 13/LO/1876
Study design
Prospective cohort observational study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please contact adrian.green@gstt.nhs.uk to request a patient information sheet
Condition
Head and Neck Cancer
Imaging (MRI and PET-CT)
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/04/2014
Overall trial end date
01/04/2018
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
01/04/2014
Recruitment end date
01/04/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College Hospital
London
SE5 9RS
United Kingdom
Sponsor information
Organisation
King's College Hospital NHS Foundation Trust (UK)
Sponsor details
161 Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)20 3299 1980
kch-tr.research@nhs.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Guy's and St Thomas' Charity
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary