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

Virginia Commonwealth University (VCU)

Status: Withdrawn

Conditions: Stage IIB Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer

Treatments: Device: diffusion-weighted magnetic resonance imaging; Radiation: fludeoxyglucose F 18; Device: 4-dimensional computed tomography; Device: FDG-PET

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02059889

MCC-13-09531

NCI-2014-00113 (Registry Identifier)

HM20000190 (Other Identifier)

MCC20000190 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 21+ years old

Volunteers: No 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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

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

Experimental group

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.

Treatment:

Device: FDG-PET

Device: 4-dimensional computed tomography

Radiation: fludeoxyglucose F 18

Device: diffusion-weighted magnetic resonance imaging