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

Not Applicable

Withdrawn

• Conditions: Recurrent Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IIB Non-small Cell Lung Cancer
• Interventions: Device: diffusion-weighted magnetic resonance imaging; Device: 4-dimensional computed tomography; Radiation: fludeoxyglucose F 18; Device: FDG-PET

• Registration Number: NCT02059889
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-10
• Study First Posted: 2014-02-11
• Study Start: 2014-07
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET)	fludeoxyglucose F 18	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.
Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET)	diffusion-weighted magnetic resonance imaging	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.
Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET)	4-dimensional computed tomography	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.
Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET)	FDG-PET	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.

Primary Outcome Measures

Name	Time	Method
Measurement of gross tumor volume and involved lymph nodes	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.
Spatial concordance of multimodality imaging for whole image registration	Up to 3 months	A paired sample t-test will be used.
Change in functional response	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.
Temporospatial registrations of radioresistant sub-volumes	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.

Secondary Outcome Measures

Name	Time	Method
Change in ADC	Baseline to 4 weeks	Fourth week ADC change will be compared to metabolic response defined by the fourth week PET using three group ANOVA and ROC analysis.

Trial Locations

Locations (1)

Virginia Commonwealth University Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States