Non Small Cell Lung CancerNCT01799135
Feasibility Study of Enhanced MRI for Early Stage Non Small Cell Lung Cancer (NSCLC)
A study testing DCE-MRI scan, Stereotactic Body Radiation Therapy and 4D-CT scan in people with Non Small Cell Lung Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This is a pilot study. A pilot study is done with a small number of participants to see if a technique works before using it in a larger research study. This pilot study is evaluating a special kind of MRI scan of the lungs called dynamic contrast enhanced MRI (DCE-MRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- DCE-MRI scan, Stereotactic Body Radiation Therapy and 4D-CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2012to Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically confirmed non-small cell lung cancer
- Tumor between 1 cm and 6 cm
- No evidence of nodal involvement or distant metastases
- Deemed to be a candidate for stereotactic body radiation therapy for NSCLC
- Able to lie still during DCE-MRI (up to 60 minutes)
- Adequate renal function to tolerate intravenous gadolinium contrast injection
Who cannot join
- Prior thoracic radiotherapy or surgery
- Implanted pacemaker or cardiac defibrillator
- Contraindications to undergoing MRI
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Feasibility Study of the Utility of Pulmonary Dynamic Contrast Enhanced MRI for Assessment of Tumor Response and Lung Injury and for Treatment Planning for Stereotactic Body Radiation Therapy for Early Stage Non-Small Cell Lung Cancer
This is a pilot study. A pilot study is done with a small number of participants to see if a technique works before using it in a larger research study. This pilot study is evaluating a special kind of MRI scan of the lungs called dynamic contrast enhanced MRI (DCE-MRI).
DCE-MRI can demonstrate how much blood flows through the tumor and lungs and tell us how active the tumor is, as well as how functional the lungs are. As part of this scan, participants will receive an intravenous (into the blood via puncture of a vein) injection of gadolinium contrast, a dye that helps us see the tumor and lung tissue more clearly. Gadolinium is approved by the FDA and is routinely used for MRI.
Read more
The goal of the study is to determine whether DCE-MRI can provide images of the response of the tumor and the normal lung tissue to SBRT and to potentially hep improve treatment-planning methods for patients treated with SBRT in the future. We will also study how the final DCE-MRI scan compares with another form of imaging, called 4-dimensional computed tomography (4D-CT), that looks at the breathing capacity of the lungs. Although we are researching the usefulness of DCE-MRI in early stage non-small cell lung cancer treated with SBRT in this study, DCE-MRI with the dye injection is not an experimental technology and is routinely used in the clinic for other indications. The 4D-CT scan is also not experimental and is used for radiation planning and imaging of the lungs.
The SBRT you will receive will be standard treatment and will not be affected by your participation in this study or by these DCE-MRI scans. That means that the findings on the scan will not be used to alter your planned treatment in any way. Additionally, participants will undergo the routine work-up prior to SBRT and surveillance studies after treatment is complete.
Read the detailed description
If you agree to participate in this research study you will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: a medical history, performance status, physical exam, assessment of tumor, assessment of breathing function and blood tests. We will also confirm that you have no contraindications to MRIs. If these tests confirm that you are eligible to participate in the research study, you will begin the study scans. If you do not meet the eligibility criteria you will not be able to participate in this research study.
If you qualify for this research study, you will come for the first study visit that will last about one and a half hours. We will use the first 30 minutes to make sure you can undergo a MRI scan (MRI screening).
Before the MRI scan, we will explain how we want you to breathe during the scan. You will breathe in small and regular breaths for one part of the exam. In another part of the exam, you will hold your breath as much as possible and breathe in between breath-holds.
An MRI contrast agent called gadolinium will be injected into a vein in your arm through an intravenous (IV) line. A contrast agent is a dye that is injected into the body to allow for better visualization (images) during an MRI exam.
You will be aked to lie down on your back on a platform that can slide into the scanner. The scan will last 60 minutes. You will hear a loud knocking or hammering noise while the MRI is taking pictures, but the process itself will be painless. You will be given disposable earplugs to help make the noise less noticeable.
During the procedure, you will be able to talk to the MRI technician through an intercom. If you feel too uncomfortable to continue the scan for any reason, the procedure will be immediately stopped and you will be removed from the MRI scanner.
You will then undergo a standard treatment planning session for SBRT. This will include a standard 4D-CT scan and a standard planning CT scan. As part of the standard planning CT scan, an intravenous (IV, through a vein) line will be placed, and you will receive an injection of IV contrast. The planning process will be conducted exactly as it would if you were not participating in this research study; it is not experimental in any way.
One to two weeks later, you will start standard SBRT treatment for your early stage non-small cell lung cancer. This treatment will be delivered exactly as it would if you were not participating in this research study; it is not experimental in any way.
After the first treatment, you will undergo your second study DCE-MRI, which is identical to the initial DCE-MRI scan as described above.
You will then have two more study visits for the post-treatment research scans. The first visit will occur 1-2 weeks after completion of SBRT. It will involve a 30-minute routine clinic visit with your radiation oncologist to assess your recovery from treatment, and then you will undergo your third study DCE-MRI, which is identical to the DCE-MRI scans described above.
You will then undergo the fourth (final) study DCE-MRI scan 3-4 months after completion of SBRT. This scan will be identical to the three previous DCE-MRI scans. At this visit, you will also have a repeat 4D-CT scan which is study related. You will also have a routine clinic visit with your radiation oncologist at this time. You will then undergo the standard post-treatment re-evaluation imaging including a repeat PET/CT and a pulmonary function test.
Once you have completed the DCE-MRI scans, no further study follow-up will be necessary. However, you will continue with routine follow-up with your radiation oncologist as part of standard care. You will be in this research study for approximately four months.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- DCE-MRI scan, Stereotactic Body Radiation Therapy, 4D-CT scan
- 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.
DCE-MRI scanOther
Stereotactic Body Radiation TherapyRadiation
4D-CT scanOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most.
DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy.
4D-CT scan 3 months after completing radiotherapy. Receives: Other: DCE-MRI scan; Radiation: Stereotactic Body Radiation Therapy; Other: 4D-CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Rate at 1-2 Days After the First SBRT Treatment and 1-2 Weeks and 3-4 Months After SBRT Treatment.
Feasibility rate is defined as the number of participants with a 20% or greater change in tumor perfusion at 1-2 days, 1-2 weeks, and 3-4 months from baseline. Feasibility must be achieved at all 3 timepoints to be considered as a success.
Perfusion measured using establish methods in conjunction with Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)
Measured: Measured 1-2 days, 1-2 weeks, and 3-4 months from baseline.
Secondary outcomes (3)
Feasibility Rate of Using Pulmonary DCE-MRI in Characterizing Acute and Subacute Radiation-induced Lung Injury
Feasibility (success) is defined as successfully enrolling patients, processing the pulmonary DCE-MRI data, and observing at least a 20% change in perfusion on the 3-month scan.
Measured: 3 months
Feasibility Rate of Using 4D-CT Ventilation Imaging With Pulmonary DCE-MRI in Characterizing Acute and Subacute Radiation Induced Lung Injury
Feasibility (success) is defined as successfully enrolling patients, processing the pulmonary DCE-MRI and 4D-CT data, and observing at least a 20% change in perfusion on the 3-month scan.
Measured: 3 months
Feasibility Rate of Using Pulmonary DCE-MRI to Identify Regions of Functional Lung for SBRT Treatment Planning
Feasibility will be defined as the ability to perform a retrospective comparative treatment planning study using the DCE-MRI images acquired prior to treatment for each participant. Regions of functional and non-functional lung will be defined on each MRI, and the images will be registered to the 4DCT used for treatment planning. The functional-lung contours will be transferred to the 4D-CT based on this registration. the treatment plan will attempt to maximize sparing of functional-lung regions while maintaining adequate target coverage and not exceeding other normal-tissue constraints. The functional-lung based treatment plans generated in this manner will be compared to the corresponding standard plans that were used to treat the patient. Changes in the functional-lung V20 and V5 will be used to analyze changes in functional-lung sparing
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionJan 2019
- Study completionFeb 2021
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond H. Mak, Dana-Farber Cancer Institute
- Investigators
- Raymond Mak, MD, Principal investigator, Dana-Farer Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799135
- Sponsor's protocol ID
- 12-004
- Status last verified
- Sep 2021
- First submitted
- 11 Dec 2012
- Last updated
- 12 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Utility of Pulmonary Dynamic Contrast Enhanced MRI for Assessment of Tumor Response and Lung Injury and for Treatment Planning for Stereotactic Body Radiation Therapy for Early Stage Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01799135
- Acronym / sponsor ID
- 12-004
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2019 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Posted 12 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study. A pilot study is done with a small number of participants to see if a technique works before using it in a larger research study. This pilot study is evaluating a special kind of MRI scan of the lungs called dynamic contrast enhanced MRI (DCE-MRI).
DCE-MRI can demonstrate how much blood flows through the tumor and lungs and tell us how active the tumor is, as well as how functional the lungs are. As part of this scan, participants will receive an intravenous (into the blood via puncture of a vein) injection of gadolinium contrast, a dye that helps us see the tumor and lung tissue more clearly. Gadolinium is approved by the FDA and is routinely used for MRI.
The goal of the study is to determine whether DCE-MRI can provide images of the response of the tumor and the normal lung tissue to SBRT and to potentially hep improve treatment-planning methods for patients treated with SBRT in the future. We will also study how the final DCE-MRI scan compares with another form of imaging, called 4-dimensional computed tomography (4D-CT), that looks at the breathing capacity of the lungs. Although we are researching the usefulness of DCE-MRI in early stage non-small cell lung cancer treated with SBRT in this study, DCE-MRI with the dye injection is not an experimental technology and is routinely used in the clinic for other indications. The 4D-CT scan is also not experimental and is used for radiation planning and imaging of the lungs.
The SBRT you will receive will be standard treatment and will not be affected by your participation in this study or by these DCE-MRI scans. That means that the findings on the scan will not be used to alter your planned treatment in any way. Additionally, participants will undergo the routine work-up prior to SBRT and surveillance studies after treatment is complete.
Detailed description
If you agree to participate in this research study you will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: a medical history, performance status, physical exam, assessment of tumor, assessment of breathing function and blood tests. We will also confirm that you have no contraindications to MRIs. If these tests confirm that you are eligible to participate in the research study, you will begin the study scans. If you do not meet the eligibility criteria you will not be able to participate in this research study.
If you qualify for this research study, you will come for the first study visit that will last about one and a half hours. We will use the first 30 minutes to make sure you can undergo a MRI scan (MRI screening).
Before the MRI scan, we will explain how we want you to breathe during the scan. You will breathe in small and regular breaths for one part of the exam. In another part of the exam, you will hold your breath as much as possible and breathe in between breath-holds.
An MRI contrast agent called gadolinium will be injected into a vein in your arm through an intravenous (IV) line. A contrast agent is a dye that is injected into the body to allow for better visualization (images) during an MRI exam.
You will be aked to lie down on your back on a platform that can slide into the scanner. The scan will last 60 minutes. You will hear a loud knocking or hammering noise while the MRI is taking pictures, but the process itself will be painless. You will be given disposable earplugs to help make the noise less noticeable.
During the procedure, you will be able to talk to the MRI technician through an intercom. If you feel too uncomfortable to continue the scan for any reason, the procedure will be immediately stopped and you will be removed from the MRI scanner.
You will then undergo a standard treatment planning session for SBRT. This will include a standard 4D-CT scan and a standard planning CT scan. As part of the standard planning CT scan, an intravenous (IV, through a vein) line will be placed, and you will receive an injection of IV contrast. The planning process will be conducted exactly as it would if you were not participating in this research study; it is not experimental in any way.
One to two weeks later, you will start standard SBRT treatment for your early stage non-small cell lung cancer. This treatment will be delivered exactly as it would if you were not participating in this research study; it is not experimental in any way.
After the first treatment, you will undergo your second study DCE-MRI, which is identical to the initial DCE-MRI scan as described above.
You will then have two more study visits for the post-treatment research scans. The first visit will occur 1-2 weeks after completion of SBRT. It will involve a 30-minute routine clinic visit with your radiation oncologist to assess your recovery from treatment, and then you will undergo your third study DCE-MRI, which is identical to the DCE-MRI scans described above.
You will then undergo the fourth (final) study DCE-MRI scan 3-4 months after completion of SBRT. This scan will be identical to the three previous DCE-MRI scans. At this visit, you will also have a repeat 4D-CT scan which is study related. You will also have a routine clinic visit with your radiation oncologist at this time. You will then undergo the standard post-treatment re-evaluation imaging including a repeat PET/CT and a pulmonary function test.
Once you have completed the DCE-MRI scans, no further study follow-up will be necessary. However, you will continue with routine follow-up with your radiation oncologist as part of standard care. You will be in this research study for approximately four months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Other: DCE-MRI scan, Radiation: Stereotactic Body Radiation Therapy, Other: 4D-CT scanStereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most. DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy. 4D-CT scan 3 months after completing radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed non-small cell lung cancer
- Tumor between 1 cm and 6 cm
- No evidence of nodal involvement or distant metastases
- Deemed to be a candidate for stereotactic body radiation therapy for NSCLC
- Able to lie still during DCE-MRI (up to 60 minutes)
Key exclusion criteria (5 listed)
- Prior thoracic radiotherapy or surgery
- Implanted pacemaker or cardiac defibrillator
- Contraindications to undergoing MRI
- Uncontrolled intercurrent illness
- Pregnant or breastfeeding
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 |
|---|---|---|
| DCE-MRI scan | Other | Experimental Arm |
| Stereotactic Body Radiation Therapy | Radiation | Experimental Arm |
| 4D-CT scan | Other | Experimental Arm |
Primary outcome
Feasibility Rate at 1-2 Days After the First SBRT Treatment and 1-2 Weeks and 3-4 Months After SBRT Treatment.
Time frame: Measured 1-2 days, 1-2 weeks, and 3-4 months from baseline.
Feasibility rate is defined as the number of participants with a 20% or greater change in tumor perfusion at 1-2 days, 1-2 weeks, and 3-4 months from baseline. Feasibility must be achieved at all 3 timepoints to be considered as a success. Perfusion measured using establish methods in conjunction with Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)
3 secondary outcomes
Feasibility Rate of Using Pulmonary DCE-MRI in Characterizing Acute and Subacute Radiation-induced Lung Injury
Time frame: 3 months
Feasibility Rate of Using 4D-CT Ventilation Imaging With Pulmonary DCE-MRI in Characterizing Acute and Subacute Radiation Induced Lung Injury
Time frame: 3 months
Feasibility Rate of Using Pulmonary DCE-MRI to Identify Regions of Functional Lung for SBRT Treatment Planning
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Raymond Mak, MD principal investigator
Dana-Farer Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCE-MRI scan, Stereotactic Body Radiation Therapy and 4D-CT scan in people with Non Small Cell Lung Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
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 5 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: stopped early, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility Rate at 1-2 Days After the First SBRT Treatment and 1-2 Weeks and 3-4 Months After SBRT Treatment. (time frame: Measured 1-2 days, 1-2 weeks, and 3-4 months from baseline.). 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 12 Oct 2021.