Lung CancerMR-LungNCT03048760
Magnetic Resonance Imaging (MRI) for the Delineation of Organs At Risk (OAR) and Target Volumes in Lung Cancer Patients
A study testing MRI scan in people with Lung Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The Christie NHS Foundation Trust is one of seven sites worldwide within the Atlantic consortium that is developing the Elekta MR-Linac (MRL) prior to commercial release at the end of 2017. The MRL allows MR images of patients to be acquired before, during and following radiotherapy (RT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Sep 2017to 21 Jan 2019
- Phase
- Interventional
- 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
Who may be able to join
- Stage I-III Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) (histological diagnosis not mandatory)
- Tumour Characteristics:
- Size ≥ 3 cm in diameter
- Positions: range of tumour positions with at least 10 of the participants having lower lobe tumours
- Patients planned for radical radiotherapy
- Eastern Co-operative Oncology Group (ECOG) Performance Status (PS) 0-2
Who cannot join
- Any contraindications to MR identified after MR safety screening including completion of an MR Safety Screening Form
- Unable to lie supine for 60 minutes
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
The Christie NHS Foundation Trust is one of seven sites worldwide within the Atlantic consortium that is developing the Elekta MR-Linac (MRL) prior to commercial release at the end of 2017. The MRL allows MR images of patients to be acquired before, during and following radiotherapy (RT). One area where The Christie is taking the lead within the consortium is the application of the MRL for lung imaging and treatment, an area where MRI has hardly been used.
MRI scans provide greater soft tissue contrast than CT scans which can aid in the accurate delineation of organs at risk (OAR) and tumour target volumes for MRL and routine treatment. In addition, MRI can provide real time imaging which can aid in the accurate motion characterisation of these volumes. The addition of functional diffusion weighted imaging (DWI) has also proven to be useful in the discrimination of malignant from benign lesions; for lymph node detection and for the differentiation of tumour from atelectasis.
Read more
Auto-contouring has the potential to speed workflows at various points in the clinical pathway. This may be inter-patient contour propagation used pre-treatment for plan creation, or may be during online or offline adaptive workflows propagating contours through imaging acquired as treatment progresses. In collaboration with industry the investigators will be testing such algorithms on these images retrospectively.
In addition, the investigators would also like to evaluate patients' experiences of CT and MRI scans and determine which scanning method is preferred. Other studies have explored patient experiences of MRI compared to CT but not in the lung cancer patient population.
Read the detailed description
Participants on this study will have two MRI scans in addition to the CT treatment planning scan, which is standard of care and cone beam CT scans during treatment, which are also standard of care. One of the MR scans will be close to the start of treatment and the other will be approximately 2 weeks after the start of radiotherapy treatment. If the patient has had a PET scan within 4 weeks of the 1st MR scan then the PET images will also be used for target volume delineation. If the PET scan > 4 weeks old, it can be repeated as per standard practice.
The MRI protocol includes up to 60 minutes of scanning which will include anatomical, respiratory dynamic and functional diffusion weighted imaging (DWI). The patient will be set up according to the treatment position on the MR scanner, using flat couch. The MR scans will not be used for clinical decision making.
Clinicians will then contour organs at risk (OARs) and target volumes on both the CT (guided by PET if available) and MRI scans and contours will be compared to determine the usefulness of MRI for radiotherapy treatment planning.
The contoured data sets will be fully anonymised, and used in house and shared with Elekta to assist with the development of automatic contouring / tumour tracking software, comparing CT to cone beam CT (CBCT) tracking (standard of care) with MR to MR tracking (experimental).
To assess experiences of MRI and CT, participants will be asked to complete baseline self-report questionnaires and additional questionnaires after MRI and CT scans. A small sample of participants will also be invited to participate in a semi-structured interview to explore their experiences in greater depth.
- Conditions
- Lung Cancer
- Being tested
- MRI scan
- Keywords
- MRI scan, Organs at Risk
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanOther
All participants will undergo 2 MRI scans - 1 at the time of their radiotherapy planning scans \& 1 after approx. 2 weeks of radiotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| MRI scan | Experimental | All participants will undergo 2 MRI scans - 1 at the time of their radiotherapy planning scan \& 1 after approx. 2 weeks of radiotherapy treatment. Receives: Other: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure differences between target and OAR volumes contoured on PET, CT and MRI images.
Measured: 18 months
Secondary outcomes (2)
Measure differences in inter-patient OAR volumes and intra-patient target and OAR volumes using MRI and CT.
Measured: 18 months
Measure patient experiences of CT and MRI using questionnaires and interviews.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start11 Sep 2017
- Primary completion21 Jan 2019
- Study completion21 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Elekta Limited
- Responsible party
- Principal investigator, Sally Falk, The Christie NHS Foundation Trust
- Investigators
- Corinne Faivre-Finn, PhD, Principal investigator, University of Manchester & The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048760
- Sponsor's protocol ID
- 17_RADIO_121
- Acronym
- MR-Lung
- Status last verified
- Jul 2019
- First submitted
- 16 Jan 2017
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The contoured data sets will be fully anonymised, and used in house and shared with Elekta to assist with the development of automatic contouring / tumour tracking software, comparing CT to cone beam CT (CBCT) tracking (standard of care) with MR to MR tracking (experimental).
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging (MRI) for the Delineation of Organs At Risk (OAR) and Target Volumes in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT03048760
- Acronym / sponsor ID
- MR-Lung / 17_RADIO_121
- Conditions
- Lung Cancer
- Keywords
- MRI scan, Organs at Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Manchester, Elekta Limited
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 9 Feb 2017 (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 Christie NHS Foundation Trust is one of seven sites worldwide within the Atlantic consortium that is developing the Elekta MR-Linac (MRL) prior to commercial release at the end of 2017. The MRL allows MR images of patients to be acquired before, during and following radiotherapy (RT). One area where The Christie is taking the lead within the consortium is the application of the MRL for lung imaging and treatment, an area where MRI has hardly been used.
MRI scans provide greater soft tissue contrast than CT scans which can aid in the accurate delineation of organs at risk (OAR) and tumour target volumes for MRL and routine treatment. In addition, MRI can provide real time imaging which can aid in the accurate motion characterisation of these volumes. The addition of functional diffusion weighted imaging (DWI) has also proven to be useful in the discrimination of malignant from benign lesions; for lymph node detection and for the differentiation of tumour from atelectasis.
Auto-contouring has the potential to speed workflows at various points in the clinical pathway. This may be inter-patient contour propagation used pre-treatment for plan creation, or may be during online or offline adaptive workflows propagating contours through imaging acquired as treatment progresses. In collaboration with industry the investigators will be testing such algorithms on these images retrospectively.
In addition, the investigators would also like to evaluate patients' experiences of CT and MRI scans and determine which scanning method is preferred. Other studies have explored patient experiences of MRI compared to CT but not in the lung cancer patient population.
Detailed description
Participants on this study will have two MRI scans in addition to the CT treatment planning scan, which is standard of care and cone beam CT scans during treatment, which are also standard of care. One of the MR scans will be close to the start of treatment and the other will be approximately 2 weeks after the start of radiotherapy treatment. If the patient has had a PET scan within 4 weeks of the 1st MR scan then the PET images will also be used for target volume delineation. If the PET scan > 4 weeks old, it can be repeated as per standard practice.
The MRI protocol includes up to 60 minutes of scanning which will include anatomical, respiratory dynamic and functional diffusion weighted imaging (DWI). The patient will be set up according to the treatment position on the MR scanner, using flat couch. The MR scans will not be used for clinical decision making.
Clinicians will then contour organs at risk (OARs) and target volumes on both the CT (guided by PET if available) and MRI scans and contours will be compared to determine the usefulness of MRI for radiotherapy treatment planning.
The contoured data sets will be fully anonymised, and used in house and shared with Elekta to assist with the development of automatic contouring / tumour tracking software, comparing CT to cone beam CT (CBCT) tracking (standard of care) with MR to MR tracking (experimental).
To assess experiences of MRI and CT, participants will be asked to complete baseline self-report questionnaires and additional questionnaires after MRI and CT scans. A small sample of participants will also be invited to participate in a semi-structured interview to explore their experiences in greater depth.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI scan | Experimental | Other: MRI scanAll participants will undergo 2 MRI scans - 1 at the time of their radiotherapy planning scan \& 1 after approx. 2 weeks of radiotherapy treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stage I-III Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) (histological diagnosis not mandatory)
- Tumour Characteristics:
- Patients planned for radical radiotherapy
- Eastern Co-operative Oncology Group (ECOG) Performance Status (PS) 0-2
Key exclusion criteria (3 listed)
- Any contraindications to MR identified after MR safety screening including completion of an MR Safety Screening Form
- Unable to lie supine for 60 minutes
- Pregnancy
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 |
|---|---|---|
| MRI scanAll participants will undergo 2 MRI scans - 1 at the time of their radiotherapy planning scans \& 1 after approx. 2 weeks of radiotherapy treatment. | Other | MRI scan |
Primary outcome
Measure differences between target and OAR volumes contoured on PET, CT and MRI images.
Time frame: 18 months
2 secondary outcomes
Measure differences in inter-patient OAR volumes and intra-patient target and OAR volumes using MRI and CT.
Time frame: 18 months
Measure patient experiences of CT and MRI using questionnaires and interviews.
Time frame: 18 months
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 8 Jul 2019.
- Individual participant dataSharing planned: Yes. The contoured data sets will be fully anonymised, and used in house and shared with Elekta to assist with the development of automatic contouring / tumour tracking software, comparing CT to cone beam CT (CBCT) tracking (standard of care) with MR to MR tracking (experimental).
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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.
Corinne Faivre-Finn, PhD principal investigator
University of Manchester & The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan in people with Lung Cancer, run by The Christie 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 6 inclusion and 3 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 8 Jul 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?
Measure differences between target and OAR volumes contoured on PET, CT and MRI images. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2019.