Stage III Non-small Cell Lung CancerNCT02076282
MRI Optimization Study in Stage III NSCLC
An observational study of Stage III Non-small Cell Lung Cancer, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Radiation therapy uses radiation to treat lung tumors and metastases in the mediastinum. In order to irradiate as precise as possible, and in order to evaluate the effect of radiation treatment, it is important to depict the lung tumor and the lymph node metastases as accurate as possible. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stage III Non-small Cell Lung Cancer
- What is being tested?
- 1 MRI scan
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2014to Nov 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: * 10 healthy volunteers * 20 patients with pathologically proven stage III NSCLC with lymph node metastases (i.e. excluding T4N0) referred to the department of Radiation Oncology.
Who may be able to join
- Healthy volunteers
- ≥18 years.
- Written informed consent
- Patients
- Patients with histopathologically or cytologically proven stage III NSCLC (excluding T4N0) referred to the department of Radiation Oncology
- ≥ 18 years.
- Written informed consent.
- Recent (≤ 21 days) GFR value available
Who cannot join
- Healthy volunteers:
- 1. Volunteers who meet exclusion criteria for MRI following the protocol of the department of Radiology of the UMC Utrecht
- Patients:
- Patients who meet exclusion criteria for MRI following the protocol of the department of Radiology of the UMC Utrecht.
- Patients for whom lying still in a supine position for 45 minutes is physically too strenuous (e.g. due to orthopnea).
- Glomerular Filtration Rate (GFR) of <30 mL/min/1.73m2 (UMCU protocol 'MRI Contra-indicaties', Version 3 January 2013).
- Patients with nephrogenic systemic fibrosis, nephrogenic fibrosing dermopathy or severe renal insufficiency (UMCU protocol 'MRI Contra-indicaties', Version 3 January 2013).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center
Utrecht, Utrecht, 3584CX
David CP Cobben, MD, PhD
Emma GG Rutten, MD
About this study
Official title: MRI for Radiotherapy Treatment Planning of Stage III NSCLC: an MRI Optimization Study in Healthy Volunteers and Patients
Radiation therapy uses radiation to treat lung tumors and metastases in the mediastinum. In order to irradiate as precise as possible, and in order to evaluate the effect of radiation treatment, it is important to depict the lung tumor and the lymph node metastases as accurate as possible. Currently, radiation oncologists use PET-CT for this purpose. However, PET-CT does have its drawbacks, and partly because of this, large volumes are irradiated in current treatment.
The investigators believe that MRI can be used to improve depiction of the tumor and lymph nodes and of their motion. However, there is currently no MRI protocol available which is aimed at improving radiotherapy.
Read more
In this study, the investigators want to select the optimal MRI settings for depiction of the lung tumor, the lymph node metastases and their movement.
The investigators plan to do this by first examining 10 healthy volunteers, followed by 20 patients with non-small cell lung cancer.
Read the detailed description
Rationale:
- Patients with stage III non-small cell lung cancer (NSCLC) have a poor survival due to inadequate loco-regional control. Increasing the dose will lead to better loco-regional control and survival. However, with the current treatment planning strategies, increasing this dose would result in intolerable toxicity of the organs at risk (OARs, healthy tissue surrounding the tumor). Therefore, new treatment planning strategies have to be developed to improve local control and therefore overall survival of patients with stage III NSCLC.
Currently, the radiation oncologist uses a combination of imaging modalities for the delineation of the lung tumor and lymph nodes: four-dimensional (4D)- computed tomography (CT) scan, CT-scan with intravenous contrast and the positron emission tomography (PET)-CT with fluorodeoxyglucose as a radioactive tracer. However these imaging modalities have some disadvantages.In current clinical practice, large treatment volumes are irradiated. This results in an increased dose to OARs. Consequently, further increasing of the dose to the tumor would result in intolerable toxicity.
The investigators believe that MRI can be used to improve visualization of the tumor and lymph nodes and characterize their motion, based on promising results in recent literature. MRI can potentially be used to obtain more accurate (thus smaller) treatment volumes. This will lead to a smaller dose to the OARs and enable safe dose escalation.
Unfortunately there are no MRI protocols in the literature available aimed at radiotherapy of lung cancer.
The objective of this study is twofold. The investigators would first like to use MRI in volunteers to select the appropriate techniques for motion compensation. Furthermore, MRI settings will be sought which can be used to image lung and mediastinal parenchyma.
Second, the investigators would like to assess the MRI sequences found in volunteers for the visualization of tumors and lymph nodes in patients with stage III NSCLC. Furthermore, the investigators would like to assess if MRI can be used for (automatic) motion characterization of tumor, lymph nodes and organs at risk.
The sequences found in this study will be used in a future study on the added value of MRI for radiotherapy treatment planning of stage III NSCLC, in which MRI will also be compared to PET-CT.
Objectives:
- To select the appropriate techniques to image lung and mediastinal parenchyma. Furthermore, MRI settings will be sought which can be used for motion compensation.
- To optimize and validate MRI for the visualization and motion characterization of tumor, lymph nodes and mediastinal parenchyma in patients with stage III NSCLC.
Study design: Observational study.
Study population:10 healthy volunteers and 20 patients with pathologically proven stage III NSCLC with lymph node metastases (i.e. excluding T4N0) referred to the department of Radiation Oncology.
Procedure: Healthy volunteers will undergo an MRI scan without intravenous contrast. Patients will undergo a contrast-enhanced MRI scan.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
- Healthy volunteers will undergo an MRI scan with a maximal duration of 45 minutes. One visit to the hospital (lasting approximately 75 minutes) is required and the healthy volunteers will receive a gift voucher with a value of 25 euros. MRI-safety screening is required before the MRI scan, and consists of routine screening according to the clinical guidelines as determined by the Department of Radiology of the UMCU.
- Patients will undergo an MRI scan with a maximal duration of 45 minutes. The total visit to the department (including patient preparation, changing of clothes etc.) will last approximately 75 minutes. For determination of renal function, a recent value of the Glomerular Filtration Rate (GFR) (≤21 days) has to be available.
After proper screening, the use of MRI is safe. The use of gadolinium contrast (Gadovist) has a very low risk of contrast induced allergy. For the patients included in the study there is no individual benefit.
- Conditions
- Stage III Non-small Cell Lung Cancer
- Being tested
- 1 MRI scan
- Keywords
- Stage III non-small cell lung cancer, Optimization, MRI, Radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 MRI scanOther
For healthy volunteers: 1 MRI scan without contrast
For patients: 1 MRI scan with contrast
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers 1 MRI scan | Healthy volunteers, recruited at the UMC Utrecht, older than 18, who do not meet the exclusion criteria of the department of Radiology.
Healthy volunteers will receive 1 MRI scan without contrast agent. Receives: Other: 1 MRI scan | |
| Patients with stage III NSCLC, 1 MRI scan | Patients with histopathologically or cytologically proven stage III NSCLC (excluding T4N0), older than 18, with a recent (≤ 21 days) GFR value available
Patients will receive 1 MRI scan with contrast agent. Receives: Other: 1 MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimization and validation of an MRI scanning protocol
The aim of this study is to optimize and validate an MRI scanning protocol for patients with stage III NSCLC aimed at radiotherapy purposes (i.e. tumor delineation and motion characterization).Optimization is defined by the quality of the images.
In healthy volunteers, the study endpoint is to select the sequences with the highest quality.
Quality of the scans will be assessed by rating the motion artifacts and visibility of the lung and mediastinal parenchyma. This will be done by a group of experts (radiologist, radiation oncologist, medical physicist, MRI physicist and a researcher).
The sequences with the highest quality will be optimized in patients. In patients, the quality will be assessed by rating of the images on the following criteria:
- Contrast between tumor/lymph nodes and their surrounding tissue.
- Depiction of tumor, lymph node and mediastinal organ motion.
- Presence of artifacts.
Measured: Healthy volunteers: 1 time point, patients: at start of radiation treatment
Secondary outcomes (1)
Power analysis
The results of this optimization study will be used for the power analysis of consecutive studies.
Measured: Healthy volunteers: one time point, patients: start of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Non-small Cell 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. van Vulpen, UMC Utrecht
- Investigators
- Marco van Vulpen, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076282
- Sponsor's protocol ID
- NL46711.041.13
- Status last verified
- Feb 2015
- First submitted
- 25 Feb 2014
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI for Radiotherapy Treatment Planning of Stage III NSCLC: an MRI Optimization Study in Healthy Volunteers and Patients
- ClinicalTrials.gov ID
- NCT02076282
- Acronym / sponsor ID
- NL46711.041.13
- Conditions
- Stage III Non-small Cell Lung Cancer
- Keywords
- Stage III non-small cell lung cancer, Optimization, MRI, Radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 3 Mar 2014 (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.
Radiation therapy uses radiation to treat lung tumors and metastases in the mediastinum. In order to irradiate as precise as possible, and in order to evaluate the effect of radiation treatment, it is important to depict the lung tumor and the lymph node metastases as accurate as possible. Currently, radiation oncologists use PET-CT for this purpose. However, PET-CT does have its drawbacks, and partly because of this, large volumes are irradiated in current treatment.
The investigators believe that MRI can be used to improve depiction of the tumor and lymph nodes and of their motion. However, there is currently no MRI protocol available which is aimed at improving radiotherapy.
In this study, the investigators want to select the optimal MRI settings for depiction of the lung tumor, the lymph node metastases and their movement.
The investigators plan to do this by first examining 10 healthy volunteers, followed by 20 patients with non-small cell lung cancer.
Detailed description
Rationale:
- Patients with stage III non-small cell lung cancer (NSCLC) have a poor survival due to inadequate loco-regional control. Increasing the dose will lead to better loco-regional control and survival. However, with the current treatment planning strategies, increasing this dose would result in intolerable toxicity of the organs at risk (OARs, healthy tissue surrounding the tumor). Therefore, new treatment planning strategies have to be developed to improve local control and therefore overall survival of patients with stage III NSCLC.
Currently, the radiation oncologist uses a combination of imaging modalities for the delineation of the lung tumor and lymph nodes: four-dimensional (4D)- computed tomography (CT) scan, CT-scan with intravenous contrast and the positron emission tomography (PET)-CT with fluorodeoxyglucose as a radioactive tracer. However these imaging modalities have some disadvantages.In current clinical practice, large treatment volumes are irradiated. This results in an increased dose to OARs. Consequently, further increasing of the dose to the tumor would result in intolerable toxicity.
The investigators believe that MRI can be used to improve visualization of the tumor and lymph nodes and characterize their motion, based on promising results in recent literature. MRI can potentially be used to obtain more accurate (thus smaller) treatment volumes. This will lead to a smaller dose to the OARs and enable safe dose escalation.
Unfortunately there are no MRI protocols in the literature available aimed at radiotherapy of lung cancer.
The objective of this study is twofold. The investigators would first like to use MRI in volunteers to select the appropriate techniques for motion compensation. Furthermore, MRI settings will be sought which can be used to image lung and mediastinal parenchyma.
Second, the investigators would like to assess the MRI sequences found in volunteers for the visualization of tumors and lymph nodes in patients with stage III NSCLC. Furthermore, the investigators would like to assess if MRI can be used for (automatic) motion characterization of tumor, lymph nodes and organs at risk.
The sequences found in this study will be used in a future study on the added value of MRI for radiotherapy treatment planning of stage III NSCLC, in which MRI will also be compared to PET-CT.
Objectives:
- To select the appropriate techniques to image lung and mediastinal parenchyma. Furthermore, MRI settings will be sought which can be used for motion compensation.
- To optimize and validate MRI for the visualization and motion characterization of tumor, lymph nodes and mediastinal parenchyma in patients with stage III NSCLC.
Study design: Observational study.
Study population:10 healthy volunteers and 20 patients with pathologically proven stage III NSCLC with lymph node metastases (i.e. excluding T4N0) referred to the department of Radiation Oncology.
Procedure: Healthy volunteers will undergo an MRI scan without intravenous contrast. Patients will undergo a contrast-enhanced MRI scan.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
- Healthy volunteers will undergo an MRI scan with a maximal duration of 45 minutes. One visit to the hospital (lasting approximately 75 minutes) is required and the healthy volunteers will receive a gift voucher with a value of 25 euros. MRI-safety screening is required before the MRI scan, and consists of routine screening according to the clinical guidelines as determined by the Department of Radiology of the UMCU.
- Patients will undergo an MRI scan with a maximal duration of 45 minutes. The total visit to the department (including patient preparation, changing of clothes etc.) will last approximately 75 minutes. For determination of renal function, a recent value of the Glomerular Filtration Rate (GFR) (≤21 days) has to be available.
After proper screening, the use of MRI is safe. The use of gadolinium contrast (Gadovist) has a very low risk of contrast induced allergy. For the patients included in the study there is no individual benefit.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers 1 MRI scan | – | Other: 1 MRI scanHealthy volunteers, recruited at the UMC Utrecht, older than 18, who do not meet the exclusion criteria of the department of Radiology. Healthy volunteers will receive 1 MRI scan without contrast agent. |
| Patients with stage III NSCLC, 1 MRI scan | – | Other: 1 MRI scanPatients with histopathologically or cytologically proven stage III NSCLC (excluding T4N0), older than 18, with a recent (≤ 21 days) GFR value available Patients will receive 1 MRI scan with contrast agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * 10 healthy volunteers * 20 patients with pathologically proven stage III NSCLC with lymph node metastases (i.e. excluding T4N0) referred to the department of Radiation Oncology.
Key inclusion criteria (8 listed)
- Healthy volunteers
- Patients
Key exclusion criteria (7 listed)
- Healthy volunteers:
- 1. Volunteers who meet exclusion criteria for MRI following the protocol of the department of Radiology of the UMC Utrecht
- Patients:
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 |
|---|---|---|
| 1 MRI scanFor healthy volunteers: 1 MRI scan without contrast For patients: 1 MRI scan with contrast | Other | Healthy volunteers 1 MRI scan, Patients with stage III NSCLC, 1 MRI scan |
Primary outcome
Optimization and validation of an MRI scanning protocol
Time frame: Healthy volunteers: 1 time point, patients: at start of radiation treatment
The aim of this study is to optimize and validate an MRI scanning protocol for patients with stage III NSCLC aimed at radiotherapy purposes (i.e. tumor delineation and motion characterization).Optimization is defined by the quality of the images. In healthy volunteers, the study endpoint is to select the sequences with the highest quality. Quality of the scans will be assessed by rating the motion artifacts and visibility of the lung and mediastinal parenchyma. This will be done by a group of experts (radiologist, radiation oncologist, medical physicist, MRI physicist and a researcher). The sequences with the highest quality will be optimized in patients. In patients, the quality will be assessed by rating of the images on the following criteria: * Contrast between tumor/lymph nodes and their surrounding tissue. * Depiction of tumor, lymph node and mediastinal organ motion. * Presence of artifacts.
1 secondary outcome
Power analysis
Time frame: Healthy volunteers: one time point, patients: start of radiation therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
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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.
Marco van Vulpen, MD, PhD principal investigator
UMC Utrecht
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 Stage III Non-small Cell Lung Cancer, run by UMC Utrecht at 1 site in Netherlands.
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 8 inclusion and 7 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 3 Feb 2015. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David CP Cobben, MD. PhD (+31887557095, d.c.p.cobben@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimization and validation of an MRI scanning protocol (time frame: Healthy volunteers: 1 time point, patients: at start of radiation treatment). 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 3 Feb 2015.