Lung CancerMRSNCT02497586
Feasibility of Magnetic Resonance Spectroscopy in Lung Cancer
A study testing Magnetic resonance spectroscopy in people with Lung Cancer, run by NHS Greater Glasgow and Clyde.
Trial summary
Lung cancer is commonly characterised either with a surgical procedure or by taking a tissue sample with a needle. Unfortunately, these invasive approaches may be unsafe in many patients with lung cancer, who often have co-existing illnesses such as emphysema. 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?
- Magnetic resonance spectroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jul 2016
- 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
- biopsy-confirmed small cell or non-small cell lung cancer
- solid intrapulmonary tumour of at least 3 cm in long and short axis diameters on transverse CT images
- ECOG performance status ≤ 2
- able to provide written informed consent and respond appropriately to verbal instructions for scan acquisition
- age 18 years or older
Who cannot join
- chemotherapy within the preceding 12 months
- previous radiotherapy to the tumour
- cardiac pacemaker/defibrillator, internal pacing wires, cerebral aneurysm clip, incompatible metallic heart valve replacements, other incompatible implants/prostheses, claustrophobia or other MRI contraindication
- history of metal entering the body or eye, unless residual metal in the affected area likely to cause harm has been adequately excluded by X-ray in the opinion of Dr Cowell or Dr Stobo
- intractable cough, inability to lie flat or other impediment to acquisition of breath-held MR images
- pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Lung cancer is commonly characterised either with a surgical procedure or by taking a tissue sample with a needle. Unfortunately, these invasive approaches may be unsafe in many patients with lung cancer, who often have co-existing illnesses such as emphysema.
Magnetic resonance spectroscopy (MRS) is a type of scan which offers the possibility of assessing tumour function by measuring concentrations of chemicals (metabolites) within the abnormal tissue. It is a well-established technique in imaging brain cancers. It has also been more recently studied in assessing prostate, liver and heart. There has been very little exploration of the potential role of MRS in lung cancer.
The proposed feasibility study will recruit 15 patients with proven lung cancer to undergo an MRS scan. The reliability of the technique for metabolite measurement will be determined by comparing repeated scans from the same region in the same tumour. Further scans from different regions in the same tumour, normal lung around the tumour and tumour regions in different patients will be used to look for any patterns in the cancer metabolites which may indicate avenues for potential future research.
Read the detailed description
Magnetic resonance spectroscopy (MRS) is a magnetic resonance imaging (MRI) application that we aim to utilise in lung cancer for the first time at a higher magnetic field strength (3 Tesla). MRS allows nuclear magnetic resonance spectra to be obtained from user-defined regions of interest (ROIs) within body tissues. These spectra can be used to quantify concentrations of tumour metabolites, providing unique biological information non-invasively and without the need for ionising radiation or intravenous contrast material. Proton MRS is a well-established technique for characterisation of brain pathology and prostate cancer. MRS in the lung is more challenging as it is a moving structure but has been shown to be feasible in a previous small study using more basic standard field strength equipment and technique. MRS of other moving structures, namely the heart and liver, has been shown to be achievable.
It is believed that MRS, using a higher field strength (3 Tesla) machine, has not been applied before in the evaluation of lung cancer in human subjects. Successful utilisation of this technology to quantify metabolite concentrations within lung cancers offers new opportunities for non-invasive tumour classification. For example, low tumour oxygen levels, a known prognostic indicator, may be identifiable by non-invasive measurement of lactate concentration by MRS. Since MRS is an easily repeatable technique without ionising radiation, it may also prove useful in response assessment following lung cancer therapies. This is a prospective feasibility study, aiming to recruit 15 consecutive patients with lung cancer to undergo proton MRS. The feasibility and repeatability of the technique will be assessed by analysis of the MR spectra obtained.
The principal research questions is: Can MRS scans be obtained in lung cancer with a high field strength (3 Tesla) MR scanner? The secondary research questions are: Is there any indication of reproducibility in the MRS signals obtained? Is there any indication of MRS patterns correlating with tumour type and other clinical parameters which might be a useful subject for further investigation in lung cancer characterisation?
Summary of interventions:
- During attendance at respiratory clinic, invite patient to participate in study and issue Patient Information Sheet (PIS), highlighting contact details for next steps (typically 5 min)
- Patients with questions may contact a study investigator using the telephone number in the PIS to have them answered (typically 5-15 min)
- Patients wishing to proceed contact the RIF using the telephone number in the PIS to arrange a convenient scan appointment and taxi transfers (typically 5 min) At least 1 day after clinic attendance
- Written informed consent obtained, pre-scan checklist completed and GP letter sent by medical member of study team. Research radiographer completes safety checklist with patient. Scan undertaken, with maximum 'on table' scan time of 1 hour.
Implications for research for future service developments:
If this early study shows MRS of lung cancer to be technically feasible, the investigators will apply for external funding for a larger prospective study or studies correlating the MRS findings with a panel of clinical, imaging, histopathological and molecular variables. These secondary studies would have potential to alter clinical practice in tumour characterisation and follow-up. The overall aim of the research would be the development of a non-invasive tool to enable diagnosis and characterisation of suspected lung cancers.
- Conditions
- Lung Cancer
- Being tested
- Magnetic resonance spectroscopy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance spectroscopyRadiation
Magnetic resonance spectroscopy (MRS) is a type of scan which offers the possibility of assessing tumour function by measuring concentrations of chemicals (metabolites) within the abnormal tissue. It is a well-established technique in imaging brain cancers.
| Study group | Role | What they receive |
|---|---|---|
| MRS | Experimental | Magnetic resonance spectroscopy (MRS) is a type of scan which offers the possibility of assessing tumour function by measuring concentrations of chemicals (metabolites) within the abnormal tissue. This is a prospective feasibility study, aiming to recruit 15 consecutive patients with lung cancer to undergo proton MRS. The feasibility and repeatability of the technique will be assessed by analysis of the MR spectra obtained. Receives: Radiation: Magnetic resonance spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of metabolite peaks
Presence of metabolite peaks in MR spectra obtained from lung tumours using a 3T MR system.
Measured: Data collected on day 1
Secondary outcomes (2)
Reproducability of metabolite peaks
Reproducibility of metabolite peak ratios in MR spectra repeatedly obtained from lung tumours using a 3T MR system.
Measured: Data collected on day 1
Metabolite peak-clinical parameter colleration
Correlation between metabolite peak ratios in MR spectra from lung tumours and clinical parameters including lung cancer type and treatment response.
Measured: Data collected on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David B Stobo, Dr, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497586
- Sponsor's protocol ID
- GN15ON255
- Acronym
- MRS
- Status last verified
- Jul 2015
- First submitted
- 15 Jun 2015
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Castillo M, Kwock L, Mukherji SK. Clinical applications of proton MR spectroscopy. AJNR Am J Neuroradiol. 1996 Jan;17(1):1-15. No abstract available.
PubMed 8770242
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Magnetic Resonance Spectroscopy in Lung Cancer
- ClinicalTrials.gov ID
- NCT02497586
- Acronym / sponsor ID
- MRS / GN15ON255
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 14 Jul 2015 (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.
Lung cancer is commonly characterised either with a surgical procedure or by taking a tissue sample with a needle. Unfortunately, these invasive approaches may be unsafe in many patients with lung cancer, who often have co-existing illnesses such as emphysema.
Magnetic resonance spectroscopy (MRS) is a type of scan which offers the possibility of assessing tumour function by measuring concentrations of chemicals (metabolites) within the abnormal tissue. It is a well-established technique in imaging brain cancers. It has also been more recently studied in assessing prostate, liver and heart. There has been very little exploration of the potential role of MRS in lung cancer.
The proposed feasibility study will recruit 15 patients with proven lung cancer to undergo an MRS scan. The reliability of the technique for metabolite measurement will be determined by comparing repeated scans from the same region in the same tumour. Further scans from different regions in the same tumour, normal lung around the tumour and tumour regions in different patients will be used to look for any patterns in the cancer metabolites which may indicate avenues for potential future research.
Detailed description
Magnetic resonance spectroscopy (MRS) is a magnetic resonance imaging (MRI) application that we aim to utilise in lung cancer for the first time at a higher magnetic field strength (3 Tesla). MRS allows nuclear magnetic resonance spectra to be obtained from user-defined regions of interest (ROIs) within body tissues. These spectra can be used to quantify concentrations of tumour metabolites, providing unique biological information non-invasively and without the need for ionising radiation or intravenous contrast material. Proton MRS is a well-established technique for characterisation of brain pathology and prostate cancer. MRS in the lung is more challenging as it is a moving structure but has been shown to be feasible in a previous small study using more basic standard field strength equipment and technique. MRS of other moving structures, namely the heart and liver, has been shown to be achievable.
It is believed that MRS, using a higher field strength (3 Tesla) machine, has not been applied before in the evaluation of lung cancer in human subjects. Successful utilisation of this technology to quantify metabolite concentrations within lung cancers offers new opportunities for non-invasive tumour classification. For example, low tumour oxygen levels, a known prognostic indicator, may be identifiable by non-invasive measurement of lactate concentration by MRS. Since MRS is an easily repeatable technique without ionising radiation, it may also prove useful in response assessment following lung cancer therapies. This is a prospective feasibility study, aiming to recruit 15 consecutive patients with lung cancer to undergo proton MRS. The feasibility and repeatability of the technique will be assessed by analysis of the MR spectra obtained.
The principal research questions is: Can MRS scans be obtained in lung cancer with a high field strength (3 Tesla) MR scanner? The secondary research questions are: Is there any indication of reproducibility in the MRS signals obtained? Is there any indication of MRS patterns correlating with tumour type and other clinical parameters which might be a useful subject for further investigation in lung cancer characterisation?
Summary of interventions:
- During attendance at respiratory clinic, invite patient to participate in study and issue Patient Information Sheet (PIS), highlighting contact details for next steps (typically 5 min)
- Patients with questions may contact a study investigator using the telephone number in the PIS to have them answered (typically 5-15 min)
- Patients wishing to proceed contact the RIF using the telephone number in the PIS to arrange a convenient scan appointment and taxi transfers (typically 5 min) At least 1 day after clinic attendance
- Written informed consent obtained, pre-scan checklist completed and GP letter sent by medical member of study team. Research radiographer completes safety checklist with patient. Scan undertaken, with maximum 'on table' scan time of 1 hour.
Implications for research for future service developments:
If this early study shows MRS of lung cancer to be technically feasible, the investigators will apply for external funding for a larger prospective study or studies correlating the MRS findings with a panel of clinical, imaging, histopathological and molecular variables. These secondary studies would have potential to alter clinical practice in tumour characterisation and follow-up. The overall aim of the research would be the development of a non-invasive tool to enable diagnosis and characterisation of suspected lung cancers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRS | Experimental | Radiation: Magnetic resonance spectroscopyMagnetic resonance spectroscopy (MRS) is a type of scan which offers the possibility of assessing tumour function by measuring concentrations of chemicals (metabolites) within the abnormal tissue. This is a prospective feasibility study, aiming to recruit 15 consecutive patients with lung cancer to undergo proton MRS. The feasibility and repeatability of the technique will be assessed by analysis of the MR spectra obtained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- biopsy-confirmed small cell or non-small cell lung cancer
- solid intrapulmonary tumour of at least 3 cm in long and short axis diameters on transverse CT images
- ECOG performance status ≤ 2
- able to provide written informed consent and respond appropriately to verbal instructions for scan acquisition
- age 18 years or older
Key exclusion criteria (6 listed)
- chemotherapy within the preceding 12 months
- previous radiotherapy to the tumour
- cardiac pacemaker/defibrillator, internal pacing wires, cerebral aneurysm clip, incompatible metallic heart valve replacements, other incompatible implants/prostheses, claustrophobia or other MRI contraindication
- history of metal entering the body or eye, unless residual metal in the affected area likely to cause harm has been adequately excluded by X-ray in the opinion of Dr Cowell or Dr Stobo
- intractable cough, inability to lie flat or other impediment to acquisition of breath-held MR images
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 |
|---|---|---|
| Magnetic resonance spectroscopyMagnetic resonance spectroscopy (MRS) is a type of scan which offers the possibility of assessing tumour function by measuring concentrations of chemicals (metabolites) within the abnormal tissue. It is a well-established technique in imaging brain cancers. | Radiation | MRS |
Primary outcome
Presence of metabolite peaks
Time frame: Data collected on day 1
Presence of metabolite peaks in MR spectra obtained from lung tumours using a 3T MR system.
2 secondary outcomes
Reproducability of metabolite peaks
Time frame: Data collected on day 1
Metabolite peak-clinical parameter colleration
Time frame: Data collected on day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- Background: PubMed 8770242Castillo M, Kwock L, Mukherji SK. Clinical applications of proton MR spectroscopy. AJNR Am J Neuroradiol. 1996 Jan;17(1):1-15. No abstract available.
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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.
David B Stobo, Dr principal investigator
NHS Greater Glasgow and Clyde
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance spectroscopy in people with Lung Cancer, run by NHS Greater Glasgow and Clyde.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David B Stobo, Dr (0141 452 3635, david.stobo2@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of metabolite peaks (time frame: Data collected on day 1). 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 NCT02497586, which also lists 1 linked publication.
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 14 Jul 2015.