19F Thoracic Radiotherapy for Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:9/29/2018
Start Date:February 16, 2018
End Date:December 1, 2019
Contact:Samantha Womack, MS
Email:sam.womack@duke.edu
Phone:9196847931

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Feasibility Study to Determine Utility of 19F MRI for Regional Pulmonary Function Assessment in Patients Receiving Thoracic Radiotherapy for Lung Cancer

The goal of this study is to determine the feasibility and efficiency of incorporating 19F MR
functional lung imaging into the routine assessment of lung cancer patients prior to thoracic
radiotherapy.

Primary Objective:

Determine feasibility by evaluating if:

PO1: Patients diagnosed with lung cancer are able to successfully complete pre- and
post-radiotherapy 19F MR imaging scans as scheduled.

Secondary Objective:

Determine efficiency by evaluating if:

SO1: Determine efficiency by evaluating if 19F MRI data can be successfully analyzed and
incorporated into the radiation planning system.

SO2: Determine efficiency by evaluating if the incorporated 19F MRI functional data can be
successfully used to generate radiotherapy plan in a timely manner.

SO3: Determine if pre- and post radiotherapy 19F MRI scans can be readily compared to observe
changes in pulmonary function.

Hypotheses Investigators hypothesize that functional 19F MR imaging assessment is feasible in
the lung cancer patient population and that the acquired images can be efficiently analyzed
and integrated into radiotherapy planning.

Inclusion Criteria:

- Subject has histologic or cytologic confirmation of lung cancer (NSCLC or Small cell)
and has been recommended thoracic radiotherapy as part of standard of care management.

- Ability to undergo MR imaging, tolerate breath hold procedures and follow direction
during the imaging process

- Karnofsky performance status ≥60, with expected survival of ≥6 months

- At least 18 years of age

- Patient is not pregnant

- Patient can be reliably reached for post-MRI follow up AE check.

- Patient able to sign a study specific informed consent form.

Exclusion Criteria:

- Any condition including, metallic implants or cardiac pacemakers that makes the
candidate ineligible for MR imaging. (MRI research screening form will be completed
prior to each MRI scan).

- Malignant pleural effusion or pericardial effusion
We found this trial at
1
site
20 Duke Medicine Circle
Durham, North Carolina 27705
Principal Investigator: Kolby Sidhu, MD
Phone: 919-684-7931
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mi
from
Durham, NC
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