19F Thoracic Radiotherapy for Lung Cancer

July 15, 2019 updated by: Hal C Charles

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

6

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center - Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients diagnosed with Lung cancer
patients diagnosed with Lung cancer and Thoracic radiotherapy
Drug: Perfluorinated Gas/Oxygen Mixture
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
6 weeks after completing RT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hal C Charles

Investigators

  • Principal Investigator: Kolby Sidhu, MD, Duke University Medical Center, Department of Radiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2018

Primary Completion (Actual)

June 25, 2019

Study Completion (Actual)

June 25, 2019

Study Registration Dates

First Submitted

October 11, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00084472

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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