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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN58327080

Enrollment

Registered

2014-02-10

Start date

2014-04-01

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer Cancer Head and neck cancer

Interventions

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 imagi

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 tumou

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026