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Completed

NCT Number: NCT03315065

19F 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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Duke University Medical Center - Cancer Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perfluorinated gas/oxygen mixture

Drug

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

Other names: Perfluorinated Propane Imaging

Primary outcomes

  1. 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

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

    Time frame: 6 weeks after completing RT

Sponsors and collaborators

Lead sponsor

Hal C Charles

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2017
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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