Recurrent Non-small Cell Lung CancerNCT02059889
Diffusion-weighted MRI for Individualized Radiation Therapy Planning of Lung Cancer
A study testing diffusion-weighted magnetic resonance imaging, 4-dimensional computed tomography and fludeoxyglucose F 18 in people with Recurrent Non-small Cell Lung Cancer and Stage IIA Non-small Cell Lung Cancer, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This clinical trial studies diffusion-weighted magnetic resonance imaging (MRI) in identifying and localizing tumors in patients with non-small cell lung cancer undergoing radiation therapy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Recurrent Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer
- What is being tested?
- diffusion-weighted magnetic resonance imaging, 4-dimensional computed tomography and fludeoxyglucose F 18
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be able to undergo MRI imaging; contrast application will be determined according to institutional guidelines; patients with lung cancer or locally recurrent lung cancer (following surgery) who are scheduled to receive external beam radiation therapy for at least 6 weeks
- Tumor visible on planning CT scan
- Negative pregnancy test for women of childbearing potential prior to study entry
Who cannot join
- Patients requiring continuous supplemental oxygen
- Patients with metal implants including pace makers and defibrillators
- Patients with cerebral aneurysm clips or middle ear implant
- Patients with pain pump, a programmable shunt, or non-surgical metal (i.e. a foreign body)
- Claustrophobic patients
- Prior radiotherapy to body area under investigation
- No vulnerable populations will be enrolled (prisoners, children, pregnant females, or institutionalized individuals)
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
About this study
This clinical trial studies diffusion-weighted magnetic resonance imaging (MRI) in identifying and localizing tumors in patients with non-small cell lung cancer undergoing radiation therapy. Diagnostic procedures such as diffusion weighted MRI may help identify where active cancer is to improve the targeting accuracy of radiotherapy. Comparing results of diagnostic procedures done before, during, and after radiation therapy may help determine how the location and volume of tumors changes over time and predict how the tumor will respond to therapy.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess diffusion-weighted MRI as an early predictor for tumor response in patients with non-small cell lung cancer (NSCLC).
II. Establish the potential of individualized radiotherapy targeting of radioresistant tumor sub-volumes.
OUTLINE:
Patients undergo diffusion-weighted MRI within 4 weeks of radiation start (baseline), during the second week of radiation therapy, during the fourth week of radiation therapy, and at 3 months after radiation therapy (post-treatment). Patients also undergo standard of care 4-dimensional (4D) computed tomography (CT) and fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) at the same time points.
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
- Being tested
- diffusion-weighted magnetic resonance imaging, 4-dimensional computed tomography, fludeoxyglucose F 18, FDG-PET
- Keywords
- Lung
- 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.
diffusion-weighted magnetic resonance imagingDevice
Also called diffusion-weighted MRI
Undergo diffusion-weighted MRI
4-dimensional computed tomographyDevice
Also called 4D-CT
Undergo 4D CT
fludeoxyglucose F 18Radiation
Also called 18FDG, 2-F18-fluoro-2-deoxyglucose, 63503-12-8, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F 18, Fluorodeoxyglucose F18
Undergo FDG-PET
FDG-PETDevice
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo FDG-PET
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET) | Experimental | Patients undergo 15 imaging studies: 5 chest CT scans, 5 chest MRI scans, 5 PET scans. Each scan will be obtained before treatment begins, weeks 2 and 4 during radiation therapy, 3 months and 1 year following radiation therapy. THe chest CT obtained pre-treatment, at 3 months post treatment and 1 year post treatment are considered routine and would be obtained regardless of study participation. The pre-treatment PET scan is also considered routine. All other scans are being done for the purposes of this research. Receives: Device: diffusion-weighted magnetic resonance imaging; Device: 4-dimensional computed tomography; Radiation: fludeoxyglucose F 18; Device: FDG-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of gross tumor volume and involved lymph nodes
A paired sample t-test could be applied to test the difference between MRI, CT, and PET-CT contours. Parameters used for comparison will include volume size, volume overlap, such as Dice similarity coefficients and Jaccard index, and surface distance maps including Hausdorff distance.
Measured: Up to 3 months
Change in functional response
Patients will be classified into responders and non-responders based on their PET signal which will serve as the reference method for response assessment. Although this is a little different from the three group analysis of variance (ANOVA) used in the power calculation, it is expected that there will be similar high power when the partial responders and non-responders are combined. Receiver operating characteristic (ROC) analysis will be used to define a threshold of apparent diffusion coefficient (ADC) change to stratify between metabolic responders vs. non-responders.
Measured: Baseline to 3 months
Spatial concordance of multimodality imaging for whole image registration
A paired sample t-test will be used.
Measured: Up to 3 months
Temporospatial registrations of radioresistant sub-volumes
A paired sample t-test will be used. ROC analysis will be performed only for radioresistant sub-volumes to identify which diffusion weighted-MRI functional signal thresholds correlate with levels of tumor activity defined on PET.
Measured: Up to 3 months
Secondary outcomes (1)
Change in ADC
Fourth week ADC change will be compared to metabolic response defined by the fourth week PET using three group ANOVA and ROC analysis.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Weiss, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059889
- Sponsor's protocol ID
- MCC-13-09531
- Other IDs
- HM20000190, MCC20000190, NCI-2014-00113
- Status last verified
- Dec 2016
- First submitted
- 7 Feb 2014
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion-weighted MRI for Individualized Radiation Therapy Planning of Lung Cancer
- ClinicalTrials.gov ID
- NCT02059889
- Acronym / sponsor ID
- MCC-13-09531
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
- Keywords
- Lung
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Feb 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.
This clinical trial studies diffusion-weighted magnetic resonance imaging (MRI) in identifying and localizing tumors in patients with non-small cell lung cancer undergoing radiation therapy. Diagnostic procedures such as diffusion weighted MRI may help identify where active cancer is to improve the targeting accuracy of radiotherapy. Comparing results of diagnostic procedures done before, during, and after radiation therapy may help determine how the location and volume of tumors changes over time and predict how the tumor will respond to therapy.
Detailed description
PRIMARY OBJECTIVES:
- Assess diffusion-weighted MRI as an early predictor for tumor response in patients with non-small cell lung cancer (NSCLC).
II. Establish the potential of individualized radiotherapy targeting of radioresistant tumor sub-volumes.
OUTLINE:
Patients undergo diffusion-weighted MRI within 4 weeks of radiation start (baseline), during the second week of radiation therapy, during the fourth week of radiation therapy, and at 3 months after radiation therapy (post-treatment). Patients also undergo standard of care 4-dimensional (4D) computed tomography (CT) and fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) at the same time points.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET) | Experimental | Device: diffusion-weighted magnetic resonance imaging, Device: 4-dimensional computed tomography, Radiation: fludeoxyglucose F 18, Device: FDG-PETPatients undergo 15 imaging studies: 5 chest CT scans, 5 chest MRI scans, 5 PET scans. Each scan will be obtained before treatment begins, weeks 2 and 4 during radiation therapy, 3 months and 1 year following radiation therapy. THe chest CT obtained pre-treatment, at 3 months post treatment and 1 year post treatment are considered routine and would be obtained regardless of study participation. The pre-treatment PET scan is also considered routine. All other scans are being done for the purposes of this research. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be able to undergo MRI imaging; contrast application will be determined according to institutional guidelines; patients with lung cancer or locally recurrent lung cancer (following surgery) who are scheduled to receive external beam radiation therapy for at least 6 weeks
- Tumor visible on planning CT scan
- Negative pregnancy test for women of childbearing potential prior to study entry
Key exclusion criteria (7 listed)
- Patients requiring continuous supplemental oxygen
- Patients with metal implants including pace makers and defibrillators
- Patients with cerebral aneurysm clips or middle ear implant
- Patients with pain pump, a programmable shunt, or non-surgical metal (i.e. a foreign body)
- Claustrophobic 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 |
|---|---|---|
| diffusion-weighted magnetic resonance imagingAlso: diffusion-weighted MRIUndergo diffusion-weighted MRI | Device | Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET) |
| 4-dimensional computed tomographyAlso: 4D-CTUndergo 4D CT | Device | Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET) |
| fludeoxyglucose F 18Also: 18FDG, 2-F18-fluoro-2-deoxyglucose, 63503-12-8, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F 18, Fluorodeoxyglucose F18Undergo FDG-PET | Radiation | Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET) |
| FDG-PETAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo FDG-PET | Device | Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET) |
Primary outcome
Measurement of gross tumor volume and involved lymph nodes
Time frame: Up to 3 months
A paired sample t-test could be applied to test the difference between MRI, CT, and PET-CT contours. Parameters used for comparison will include volume size, volume overlap, such as Dice similarity coefficients and Jaccard index, and surface distance maps including Hausdorff distance.
Change in functional response
Time frame: Baseline to 3 months
Patients will be classified into responders and non-responders based on their PET signal which will serve as the reference method for response assessment. Although this is a little different from the three group analysis of variance (ANOVA) used in the power calculation, it is expected that there will be similar high power when the partial responders and non-responders are combined. Receiver operating characteristic (ROC) analysis will be used to define a threshold of apparent diffusion coefficient (ADC) change to stratify between metabolic responders vs. non-responders.
Spatial concordance of multimodality imaging for whole image registration
Time frame: Up to 3 months
A paired sample t-test will be used.
Temporospatial registrations of radioresistant sub-volumes
Time frame: Up to 3 months
A paired sample t-test will be used. ROC analysis will be performed only for radioresistant sub-volumes to identify which diffusion weighted-MRI functional signal thresholds correlate with levels of tumor activity defined on PET.
1 secondary outcome
Change in ADC
Time frame: Baseline to 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
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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.
Elisabeth Weiss, MD principal investigator
Massey Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diffusion-weighted magnetic resonance imaging, 4-dimensional computed tomography and fludeoxyglucose F 18 in people with Recurrent Non-small Cell Lung Cancer and Stage IIA Non-small Cell Lung Cancer, run by Virginia Commonwealth University at 1 site 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 3 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: withdrawn, as of the sponsor's last update on 16 Dec 2016. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Measurement of gross tumor volume and involved lymph nodes (time frame: Up to 3 months). The study lists 4 primary outcomes in all. 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 16 Dec 2016.