NCT06032663

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. 1.Comparing the radiotherapy target volumes and radiotherapy plans with and without the use of a PET-MRI scan.
  2. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 2, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

September 4, 2023

Last Update Submit

April 22, 2024

Conditions

Head and Neck Cancer

Keywords

HeadNeckCancerPET MRI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Impact of additional PET-MRI on radiotherapy target volumes

    12 months

  • Impact of additional PET-MRI on treatment plan

    12 months

  • Impact of additional PET-MRI on treatment plan

    12 months

Other Outcomes (1)

  • Added benefit to diagnostic investigations

    12 months

Study Arms (1)

PET-MRI within 1 week of planning scan.

EXPERIMENTAL

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

Interventions

PET-MRIDIAGNOSTIC_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.

PET-MRI within 1 week of planning scan.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or over
  • Able to give informed written consent.
  • New diagnosis of biopsy-proven head and neck cancer.
  • WHO performance status ≤ 2.
  • MDT-recommended treatment with radical radiotherapy, with or without concurrent systemic therapy.
  • MRI and PET-CT staging scans for diagnosis.

You may not qualify if:

  • Known intolerance/sensitivity to 18F-2-deoxyglucose or gadolinium-containing contrast agents.
  • Claustrophobia or other contraindications to MRI.
  • Unable to pass through a 55 cm hula hoop.
  • Female patients that are pregnant or breastfeeding.
  • Unable to understand written or spoken English.
  • Patients not undergoing radical intent radiotherapy.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Officials

  • Satya Garikipati, MD

    STH Contracted Consultant

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominic Nash

CONTACT

01142265208sth.specialisedcancerresearchadministration@nhs.net

Satya Garikipati, MD

CONTACT

01142265208s.garikipati@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 13, 2023

Study Start

January 2, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

IPD will not be available/shared outside the study

Locations

GB(1)