Lung HeXeRT: Helium, Xenon MRI for NSCLC Patients (HeXeRT)

September 25, 2019 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Lung HeXeRT: Advanced Proton, Hyperpolarised 3-helium and 129-xenon Magnetic Resonance Imaging for Lung Cancer Radiotherapy Planning and Evaluation

The University of Sheffield is one of the leading centres in the world for basic and translational research with inhaled gas MRI, which provides lung images with unprecedented spatial and temporal resolution. Our previous work demonstrated that inhaled gas MRI can provide significant clinical information for lung cancer radiotherapy planning and post-treatment evaluation. Building upon this unique experience, a multidisciplinary team will conduct an inhaled gas and proton lung MRI study that will address two of the major clinical problems faced by lung cancer patients treated with radiotherapy.

  1. Normal lung tissue is often damaged by the curative radiation dose. The investigators hypothesise that regional ventilation-perfusion lung function imaging with inhaled gas and proton MRI before and after treatment will help to lower the risk of radiation-induced lung injury and help to detect such damage at an early stage.
  2. Identification of the extent of cancerous tissue is error-prone when planning treatment from CT images alone. The investigators hypothesise that advanced proton MRI techniques will improve the identification of tumour volume, which is critical to successfully targeting the radiation dose.

To achieve these goals, image acquisition and image processing methods will be tested with a study of 20 patients. Results from this study will make an important contribution to improving the treatment of lung disease which is one of the key research priorities of the NHS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Sheffield, United Kingdom, S10 2SJ
        • Sheffield Teaching Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with NSCLC attending Weston Park Hospital, Sheffield, UK.

Description

Inclusion Criteria:

  • Patients with an MDT diagnosis of NSCLC based on findings of positive histology, positive PET scan or growth on serial CT scan requiring CT planning for radiotherapy treatment
  • patients aged over 18
  • patients able to undergo MRI scanning.

Exclusion Criteria:

  • patients with co-morbid conditions that exclude radiotherapy treatment
  • patients who are pregnant or women with child bearing potential
  • patients unable to give informed consent
  • patients who do not understand English sufficiently to read the patient information sheet, provide informed consent or converse with research staff without interpreters.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NSCLC patients undergoing RT
Other: MR and CT imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of ventilated lung measured using inhaled gas MRI
Time Frame: Change between pre treatment (average 10 days before start of treatment) and at 3 months post treatment
Change between pre treatment (average 10 days before start of treatment) and at 3 months post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Lung tumour volume measured using proton MRI
Time Frame: Change between pre-treatment (average 10 days before start of treatment) and at 3 months post treatment
Change between pre-treatment (average 10 days before start of treatment) and at 3 months post treatment
Percentage of ventilated lung measured using CT
Time Frame: Change between pre-treatment (average of 10 days before start of treatment) and at 3 months post-treatment
Change between pre-treatment (average of 10 days before start of treatment) and at 3 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

University of Sheffield
Weston Park Hospital Cancer Charity
Sheffield Hospitals Charity

Investigators

  • Principal Investigator: Matthew Q Hatton, FRCR, FRCP, University of Sheffield

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2014

Primary Completion (Actual)

August 8, 2019

Study Completion (Actual)

August 8, 2019

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • STH17245

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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