Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications

Sheffield Teaching Hospitals NHS Foundation Trust10 enrolled

Overview

The primary research question to be answered in this project is "Are patients with locally-advanced head and neck cancer able to tolerate a PET-MRI scan when they are immobilised in a radiotherapy treatment shell?" This will be assessed by measuring the proportion of patients that complete the full scanning protocol and by obtaining participant feedback on their experience of completing the scan. The secondary question is "Can a PET-MRI scan fused with a planning CT scan improve the accuracy in radiotherapy planning of patients with head and neck cancer? Accuracy will be assessed by: 1. Comparing the radiotherapy target volumes and radiotherapy plans with and without the use of a PET-MRI scan. 2. Comparing inter- and intra-observer variability in treatment contours with and without the use of a PET-MRI scan within and between oncologists and implications of that.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18 years or over 2. Able to give informed written consent. 3. New diagnosis of biopsy-proven head and neck cancer. 4. WHO performance status ≤ 2. 5. MDT-recommended treatment with radical radiotherapy, with or without concurrent systemic therapy. 6. MRI and PET-CT staging scans for diagnosis. Exclusion Criteria: 1. Known intolerance/sensitivity to 18F-2-deoxyglucose or gadolinium-containing contrast agents. 2. Claustrophobia or other contraindications to MRI. 3. Unable to pass through a 55 cm hula hoop. 4. Female patients that are pregnant or breastfeeding. 5. Unable to understand written or spoken English. 6. Patients not undergoing radical intent radiotherapy. 7. Patients with stage 4 or 5 chronic kidney disease or other biochemical abnormalities e.g. uncontrolled blood glucose levels which can have an impact on PET-MRI imaging or contrast administration.

Outcomes

Primary Outcomes

Completion of PET-MRI

To assess the proportion of patients completing the full PET-MRI scans when they are immobilised in a radiotherapy treatment shell.

Time frame: 12 months

Secondary Outcomes

Impact of additional PET-MRI on radiotherapy target volumes

The secondary objective is to compare the radiotherapy target volumes between conditions (with vs without the use of PET-MRI scan)

Time frame: 12 months

Impact of additional PET-MRI on treatment plan

Assess inter- and intra-observer variability in treatment contours and precision of target delineation in the three categories above (CT, CT-MRI, and CT-PET-MRI scans). This will be assessed using Hausdorff distance in the three categories.

Time frame: 12 months

Impact of additional PET-MRI on treatment plan

Time frame: 12 months

Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts