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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
Collaborators:
University of Sheffield
Weston Park Hospital Cancer Charity
Sheffield Hospitals Charity
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01859650
First received: May 10, 2013
Last updated: May 4, 2017
Last verified: May 2017
  Purpose

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 Intervention
NSCLC
Other: MR and CT imaging

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • 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 ]

Estimated Enrollment: 20
Actual Study Start Date: December 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NSCLC patients undergoing RT Other: MR and CT imaging

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with NSCLC attending Weston Park Hospital, Sheffield, UK.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859650

Contacts
Contact: Matthew Q Hatton, FRCR, FRCP matthew.hatton@sth.nhs.uk

Locations
United Kingdom
Sheffield Teaching Hospitals Recruiting
Sheffield, United Kingdom, S10 2SJ
Principal Investigator: Matthew Q Hatton, FRCR, FRCP         
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
  More Information

Publications:
Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01859650     History of Changes
Other Study ID Numbers: STH17245
Study First Received: May 10, 2013
Last Updated: May 4, 2017

ClinicalTrials.gov processed this record on May 24, 2017