NSCLCHeXeRTNCT01859650
Lung HeXeRT: Helium, Xenon MRI for NSCLC Patients
An observational study of NSCLC, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- MR and CT imaging
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Dec 2014to 8 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NSCLC attending Weston Park Hospital, Sheffield, UK.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- 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.
- 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.
- Conditions
- NSCLC
- Being tested
- MR and CT imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR and CT imagingOther
| Study group | Role | What they receive |
|---|---|---|
| NSCLC patients undergoing RT | Not described Receives: Other: MR and CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of ventilated lung measured using inhaled gas MRI
Measured: 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
Measured: Change between pre-treatment (average 10 days before start of treatment) and at 3 months post treatment
Percentage of ventilated lung measured using CT
Measured: Change between pre-treatment (average of 10 days before start of treatment) and at 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study start11 Dec 2014
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, Weston Park Hospital Cancer Charity, Sheffield Hospitals Charity
- Responsible party
- Sponsor
- Investigators
- Matthew Q Hatton, FRCR, FRCP, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859650
- Sponsor's protocol ID
- STH17245
- Acronym
- HeXeRT
- Status last verified
- Sep 2019
- First submitted
- 10 May 2013
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20821726Ireland 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.
PubMed 20724011Bates 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.
PubMed 19552978Ireland 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.
PubMed 18843168Ireland 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.
PubMed 17448880
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung HeXeRT: Advanced Proton, Hyperpolarised 3-helium and 129-xenon Magnetic Resonance Imaging for Lung Cancer Radiotherapy Planning and Evaluation
- ClinicalTrials.gov ID
- NCT01859650
- Acronym / sponsor ID
- HeXeRT / STH17245
- Conditions
- NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield, Weston Park Hospital Cancer Charity, Sheffield Hospitals Charity
- Study start
- 11 Dec 2014 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC patients undergoing RT | – | Other: MR and CT imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NSCLC attending Weston Park Hospital, Sheffield, UK.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR and CT imaging | Other | NSCLC patients undergoing RT |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 20821726Wild 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.
- Background: PubMed 20724011Ireland 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.
- Background: PubMed 19552978Bates 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.
- Background: PubMed 18843168Ireland 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.
- Background: PubMed 17448880Ireland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Q Hatton, FRCR, FRCP principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859650, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.