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Diffusion-weighted MRI for Individualized Radiation Therapy Planning of Lung Cancer

Primary Purpose

Recurrent Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diffusion-weighted magnetic resonance imaging
4-dimensional computed tomography
fludeoxyglucose F 18
FDG-PET
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Recurrent Non-small Cell Lung Cancer focused on measuring Lung

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Virginia Commonwealth University Massey Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
Spatial concordance of multimodality imaging for whole image registration
A paired sample t-test will be used.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 7, 2014
Last Updated
December 15, 2016
Sponsor
Virginia Commonwealth University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02059889
Brief Title
Diffusion-weighted MRI for Individualized Radiation Therapy Planning of Lung Cancer
Official Title
Diffusion-weighted MRI for Individualized Radiation Therapy Planning of Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
slow accrual
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
diffusion-weighted magnetic resonance imaging
Other Intervention Name(s)
diffusion-weighted MRI
Intervention Description
Undergo diffusion-weighted MRI
Intervention Type
Device
Intervention Name(s)
4-dimensional computed tomography
Other Intervention Name(s)
4D-CT
Intervention Description
Undergo 4D CT
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Other Intervention Name(s)
18FDG, 2-F18-fluoro-2-deoxyglucose, 63503-12-8, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F 18, Fluorodeoxyglucose F18
Intervention Description
Undergo FDG-PET
Intervention Type
Device
Intervention Name(s)
FDG-PET
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Undergo FDG-PET
Primary Outcome Measure Information:
Title
Measurement of gross tumor volume and involved lymph nodes
Description
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.
Time Frame
Up to 3 months
Title
Change in functional response
Description
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.
Time Frame
Baseline to 3 months
Title
Spatial concordance of multimodality imaging for whole image registration
Description
A paired sample t-test will be used.
Time Frame
Up to 3 months
Title
Temporospatial registrations of radioresistant sub-volumes
Description
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.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Change in ADC
Description
Fourth week ADC change will be compared to metabolic response defined by the fourth week PET using three group ANOVA and ROC analysis.
Time Frame
Baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Weiss, MD
Organizational Affiliation
Massey Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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Diffusion-weighted MRI for Individualized Radiation Therapy Planning of Lung Cancer

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