Lung HeXeRT: Helium, Xenon MRI for NSCLC Patients

NCT01859650 | Completed DMC

• 1 other identifier: STH17245
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• Lung tumour volume measured using proton MRI

  Change between pre-treatment (average 10 days before start of treatment) and at 3 months post treatment

• 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

Study Arms (1)

NSCLC patients undergoing RT

Other: MR and CT imaging

Interventions

MR and CT imaging OTHER

NSCLC patients undergoing RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Sheffield Teaching Hospitals

Sheffield, S10 2SJ, United Kingdom

Location

Related Publications (5)

• Wild JM, Ajraoui S, Deppe MH, Parnell SR, Marshall H, Parra-Robles J, Ireland RH. Synchronous acquisition of hyperpolarised 3He and 1H MR images of the lungs - maximising mutual anatomical and functional information. NMR Biomed. 2011 Feb;24(2):130-4. doi: 10.1002/nbm.1565. Epub 2010 Sep 6.

  PMID: 20821726 BACKGROUND

• Ireland RH, Din OS, Swinscoe JA, Woodhouse N, van Beek EJ, Wild JM, Hatton MQ. Detection of radiation-induced lung injury in non-small cell lung cancer patients using hyperpolarized helium-3 magnetic resonance imaging. Radiother Oncol. 2010 Nov;97(2):244-8. doi: 10.1016/j.radonc.2010.07.013. Epub 2010 Aug 17.

  PMID: 20724011 BACKGROUND

• Bates EL, Bragg CM, Wild JM, Hatton MQ, Ireland RH. Functional image-based radiotherapy planning for non-small cell lung cancer: A simulation study. Radiother Oncol. 2009 Oct;93(1):32-6. doi: 10.1016/j.radonc.2009.05.018. Epub 2009 Jun 22.

  PMID: 19552978 BACKGROUND

• Ireland RH, Woodhouse N, Hoggard N, Swinscoe JA, Foran BH, Hatton MQ, Wild JM. An image acquisition and registration strategy for the fusion of hyperpolarized helium-3 MRI and x-ray CT images of the lung. Phys Med Biol. 2008 Nov 7;53(21):6055-63. doi: 10.1088/0031-9155/53/21/011. Epub 2008 Oct 9.

  PMID: 18843168 BACKGROUND

• Ireland RH, Bragg CM, McJury M, Woodhouse N, Fichele S, van Beek EJ, Wild JM, Hatton MQ. Feasibility of image registration and intensity-modulated radiotherapy planning with hyperpolarized helium-3 magnetic resonance imaging for non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):273-81. doi: 10.1016/j.ijrobp.2006.12.068.

  PMID: 17448880 BACKGROUND

Study Officials

• Matthew Q Hatton, FRCR, FRCP

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 22, 2013
• Study Start: December 11, 2014
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

GB (1)