19F Thoracic Radiotherapy for Lung Cancer

Early Phase 1CompletedNCT03315065

Hal C Charles6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

Perfluorinated Gas/Oxygen MixtureDRUG

19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas and Mixture of 30% perfluoropropane and 70% oxygen to measure perfusion single visit, \< 1 hour

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center - Cancer Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Number of study patients consented (maximum 8)in order to result in 5 patients successfully completing both 19F functional MR imaging data sets

Time frame: 4 months

Proportion of study patients that successfully return for a re-assessment 19F MRI scan after completing radiotherapy.

Time frame: 6 weeks after completing RT

Data from ClinicalTrials.gov

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