PET/MR in Radiotherapy for Head and Neck Cancer Pilot

This is a pilot non-intervention study that aims to introduce PET/MRI, a state of the art new imaging technique, into the radiotherapy treatment pathway of patients with head and neck cancer. Ultimately the investigators aim to establish appropriate scanning and image registration protocols, to allow progression to a randomized trial of adaptive radiotherapy dose escalation. The latter is thought to potentially improve outcomes in this group.

Ten patients with squamous cell carcinoma (SCC) of the oropharynx, hypopharynx and larynx, planned for radical treatment with radiotherapy (+/-chemotherapy), will be recruited. Study participants will have two PET/MRI scans, with the radiotherapy immobilization devices in situ. The first will be done prior to the start of radiotherapy, the second half way through treatment.

Image quality will be assessed by comparing to standard diagnostic scans and different registration methods will be compared to establish the best way of incorporating PET/MR image data into the radiotherapy planning system. Patient tolerability and workflow considerations will also be qualitatively assessed. Furthermore, a planning study will be conducted to establish relevant treatment protocols for a subsequent dose escalation trial.

PET/MRI is an exciting new technology with a lot of potential in the context of adaptive radiotherapy dose escalation. Within this pilot study the investigators aim to address the technical challenges of using it in this context prior to proceeding to a randomized trial.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written, voluntary, informed consent
Age ≥ 18
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
Life expectancy > 12 months
Histologically proven SCC of the oropharynx, hypopharynx and larynx
Radical radiotherapy +/- chemotherapy indicated as the primary treatment modality
Visible disease (>1cm) at the primary site on any imaging modality performed within 4 weeks of starting radiotherapy treatment
Staging PET/CT and diagnostic MRI of the head and neck images need to be available for comparison.
Adequate organ function and absence of other major concurrent illness, allowing the patient to tolerate scanning regime

Exclusion criteria

Inability to provide informed consent
Impaired renal function (serum creatinine of > 200)
Severely impaired liver function
Patients with allergies or contra-indications to the radio-tracer and/or contrast agent used in the study
Severe claustrophobia or inability to tolerate PET or MRI scans
General contra-indications to MRI, as defined in MRI safety departmental protocols
Serious inter-current conditions or other non-malignant illnesses that are uncontrolled or whose control may be affected by participation in this study
Any patient who has urinary or faecal incontinence
ECOG Performance Status ≥ 3
Pregnant or breastfeeding women

Treatment and study plan

Imaging

Other

Single arm Imaging (PET/MR) study

Primary outcomes

Number of scans where image quality is sufficient to characterise the primary tumour, assessed qualitatively by an experienced radiologist and oncologist

Time frame: 6 months following study completion
Proportion of patients that tolerated the full scanning protocol, assessed by tailored patient questionnaire

Time frame: 6 months following study completion

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

An Exploratory Study to Assess the Feasibility of Incorporating PET/MR in the Radiotherapy Pathway of Patients With Head and Neck Cancer and Guide Adaptive Dose Escalation

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Nov 2, 2016
Registry last updated: Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed