PET/MR in Radiotherapy for Head and Neck Cancer Pilot

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952625
• Other study ID #: RJ116/N013
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2019
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Imaging
Single arm Imaging (PET/MR) study

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of patients that tolerated the full scanning protocol, assessed by tailored patient questionnaire		6 months following study completion