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

NCT ID: NCT06032663

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2025-10-31

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PET-MRI

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Satya Garikipati, MD

Role: PRINCIPAL_INVESTIGATOR

STH Contracted Consultant

Locations

Cancer Research Centre at Weston Park Hospital

Sheffield, England, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Dominic Nash

Role: CONTACT

sth.specialisedcancerresearchadministration@nhs.net

01142265208

Satya Garikipati, MD

Role: CONTACT

s.garikipati@nhs.net

01142265208

Facility Contacts

Contact Person

Role: primary

44-141-201-4200

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

286722

Identifier Type: OTHER

Identifier Source: secondary_id

STH21185

Identifier Type: -

Identifier Source: org_study_id