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Completed

NCT Number: NCT01859650

Lung HeXeRT: Helium, Xenon MRI for NSCLC Patients

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheffield Teaching Hospitals

Sheffield, S10 2SJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

MR and CT imaging

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • Sheffield Hospitals Charity
  • University of Sheffield
  • Weston Park Hospital Cancer Charity

Registry information

Official study title

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

Acronym: HeXeRT

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 22, 2013
Registry last updated
Sep 26, 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.

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