PET/MR in Radiotherapy for Head and Neck Cancer Pilot

Guy's and St Thomas' NHS Foundation Trust

Status

Completed

Conditions

Head and Neck Cancer

Treatments

Other: Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT02952625

RJ116/N013

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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