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

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 Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Diagnostic test: PET-MRI

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominic Nash; Phone Number: 01142265208; Email: sth.specialisedcancerresearchadministration@nhs.net
• Study Contact Backup: Name: Satya Garikipati, MD; Phone Number: 01142265208; Email: s.garikipati@nhs.net

Study Locations

• United Kingdom
  • England
    • Sheffield, England, United Kingdom, S1O 2SJ
      • Recruiting
      • Cancer Research Centre at Weston Park Hospital
      • Contact: Contact Person; Phone Number: 44-141-201-4200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET-MRI within 1 week of planning scan.; 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.	Diagnostic test: PET-MRI; Patients that participate in the current study will have an extra PET-MRI scan, which will expose them to a small amount (4 - 6 mSv) of extra radiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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 Dice Similarity Index in the three categories.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Added benefit to diagnostic investigations	Clinical reports of the PET-MRI scan will be compared to reports from staging MRI and PET-CT scans to determine if any new diagnostic information is brought to light by PET-MRI.	12 months

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Satya Garikipati, MD, STH Contracted Consultant

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Head; PET MRI; Neck
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: STH21185; 286722 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be available/shared outside the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No