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

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Diagnostic Test: PET-MRI

• Registration Number: NCT06032663
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-13
• Study Start: 2024-01-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-25
• Primary Completion: 2024-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET-MRI within 1 week of planning scan.	PET-MRI	Patients would not normally have a PET-MRI as well as planning scan. In this experimental arm, patients will be given a PET-MRI within 1 week of the planning scan.

Primary Outcome Measures

Name	Time	Method
Completion of PET-MRI	12 months	To assess the proportion of patients completing the full PET-MRI scans when they are immobilised in a radiotherapy treatment shell.

Secondary Outcome Measures

Name	Time	Method
Impact of additional PET-MRI on radiotherapy target volumes	12 months	The secondary objective is to compare the radiotherapy target volumes between conditions (with vs without the use of PET-MRI scan)
Impact of additional PET-MRI on treatment plan	12 months	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 Dice Similarity Index in the three categories.

Trial Locations

Locations (1)

Cancer Research Centre at Weston Park Hospital; 🇬🇧 Sheffield, England, United Kingdom