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

NCT ID: NCT02059889

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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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

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Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

diffusion-weighted magnetic resonance imaging

Intervention Type DEVICE

Undergo diffusion-weighted MRI

4-dimensional computed tomography

Intervention Type DEVICE

Undergo 4D CT

fludeoxyglucose F 18

Intervention Type RADIATION

Undergo FDG-PET

FDG-PET

Intervention Type DEVICE

Undergo FDG-PET

Interventions

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diffusion-weighted magnetic resonance imaging

Undergo diffusion-weighted MRI

Intervention Type DEVICE

4-dimensional computed tomography

Undergo 4D CT

Intervention Type DEVICE

fludeoxyglucose F 18

Undergo FDG-PET

Intervention Type RADIATION

FDG-PET

Undergo FDG-PET

Intervention Type DEVICE

Other Intervention Names

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diffusion-weighted MRI 4D-CT 18FDG, 2-F18-fluoro-2-deoxyglucose, 63503-12-8, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F 18, Fluorodeoxyglucose F18 FDG-PET, PET, PET scan, tomography, emission computed

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Massey Cancer Center

Locations

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Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HM20000190

Identifier Type: OTHER

Identifier Source: secondary_id

MCC20000190

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2014-00113

Identifier Type: REGISTRY

Identifier Source: secondary_id

MCC-13-09531

Identifier Type: -

Identifier Source: org_study_id