Lung HeXeRT: Helium, Xenon MRI for NSCLC Patients

Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT01859650
Collaborator
University of Sheffield (Other), Weston Park Hospital Cancer Charity (Other), Sheffield Hospitals Charity (Other)
21
1
55.9
0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: MR and CT imaging

Study Design

Study Type:
Observational
Actual Enrollment :
21 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Lung HeXeRT: Advanced Proton, Hyperpolarised 3-helium and 129-xenon Magnetic Resonance Imaging for Lung Cancer Radiotherapy Planning and Evaluation
Actual Study Start Date :
Dec 11, 2014
Actual Primary Completion Date :
Aug 8, 2019
Actual Study Completion Date :
Aug 8, 2019

Arms and Interventions

Arm Intervention/Treatment
NSCLC patients undergoing RT

Other: MR and CT imaging

Outcome Measures

Primary Outcome Measures

  1. Percentage of ventilated lung measured using inhaled gas MRI [Change between pre treatment (average 10 days before start of treatment) and at 3 months post treatment]

Secondary Outcome Measures

  1. Lung tumour volume measured using proton MRI [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 [Change between pre-treatment (average of 10 days before start of treatment) and at 3 months post-treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sheffield Teaching Hospitals Sheffield United Kingdom S10 2SJ

Sponsors and Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust
  • University of Sheffield
  • Weston Park Hospital Cancer Charity
  • Sheffield Hospitals Charity

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01859650
Other Study ID Numbers:
  • STH17245
First Posted:
May 22, 2013
Last Update Posted:
Sep 26, 2019
Last Verified:
Sep 1, 2019

Study Results

No Results Posted as of Sep 26, 2019