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

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ClinicalTrials.gov Identifier: NCT02059889
Recruitment Status : Withdrawn (slow accrual)
First Posted : February 11, 2014
Last Update Posted : December 16, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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 Device: diffusion-weighted magnetic resonance imaging Device: 4-dimensional computed tomography Radiation: fludeoxyglucose F 18 Device: FDG-PET Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diffusion-weighted MRI for Individualized Radiation Therapy Planning of Lung Cancer
Study Start Date : July 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (diffusion-weighted MRI, 4D CT, 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.
Device: diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
Other Name: diffusion-weighted MRI

Device: 4-dimensional computed tomography
Undergo 4D CT
Other Name: 4D-CT

Radiation: fludeoxyglucose F 18
Undergo FDG-PET
Other Name: 18FDG, 2-F18-fluoro-2-deoxyglucose, 63503-12-8, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F 18, Fluorodeoxyglucose F18

Device: FDG-PET
Undergo FDG-PET
Other Name: FDG-PET, PET, PET scan, tomography, emission computed




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Spatial concordance of multimodality imaging for whole image registration [ Time Frame: Up to 3 months ]
    A paired sample t-test will be used.

  4. 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.


Secondary Outcome Measures :
  1. Change in ADC [ Time Frame: 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059889


Locations
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Elisabeth Weiss, MD Massey Cancer Center

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02059889     History of Changes
Other Study ID Numbers: MCC-13-09531
HM20000190 ( Other Identifier: VCU IRB )
MCC20000190 ( Other Identifier: VCU Massey Cancer Center )
NCI-2014-00113 ( Registry Identifier: NCI CTRP )
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016

Keywords provided by Virginia Commonwealth University:
Lung

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Fluorodeoxyglucose F18
Deoxyglucose
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents