PET/MR in Radiotherapy for Head and Neck Cancer Pilot

Sponsor

Guy's and St Thomas' NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT02952625

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Other: Imaging	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official 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

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Single arm imaging study Single arm study: all patients have 2 PET/MR scans in the radiotherapy treatment position	Other: Imaging Single arm Imaging (PET/MR) study

Arm

Intervention/Treatment

Other: Single arm imaging study

Single arm study: all patients have 2 PET/MR scans in the radiotherapy treatment position

Other: Imaging

Single arm Imaging (PET/MR) study

Outcome Measures

Primary Outcome Measures

Number of scans where image quality is sufficient to characterise the primary tumour, assessed qualitatively by an experienced radiologist and oncologist [6 months following study completion]
Proportion of patients that tolerated the full scanning protocol, assessed by tailored patient questionnaire [6 months following study completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guy's & St Thomas' NHS Foundation Trust	London		United Kingdom

Sponsors and Collaborators

Guy's and St Thomas' NHS Foundation Trust

Investigators

Principal Investigator: Teresa Guerrero Urbano, Guy's & St Thomas' NHS Foundation Trust, London, UK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guy's and St Thomas' NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT02952625

Other Study ID Numbers:

RJ116/N013

First Posted:

Nov 2, 2016

Last Update Posted:

Aug 29, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Guy's and St Thomas' NHS Foundation Trust

PET/MRI

Additional relevant MeSH terms:

Head and Neck Neoplasms

Study Results

No Results Posted as of Aug 29, 2019