Back to results19F Thoracic Radiotherapy for Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Perfluorinated Gas/Oxygen Mixture
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring thoracic Radiation therapy, Lung Function
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center - Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients diagnosed with Lung cancer
Arm Description
patients diagnosed with Lung cancer and Thoracic radiotherapy
Outcomes
Primary Outcome Measures
Number of study patients consented (maximum 8)in order to result in 5 patients successfully completing both 19F functional MR imaging data sets
Proportion of study patients that successfully return for a re-assessment 19F MRI scan after completing radiotherapy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03315065
Brief Title
19F Thoracic Radiotherapy for Lung Cancer
Official Title
Feasibility Study to Determine Utility of 19F MRI for Regional Pulmonary Function Assessment in Patients Receiving Thoracic Radiotherapy for Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 16, 2018 (Actual)
Primary Completion Date
June 25, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hal C Charles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
thoracic Radiation therapy, Lung Function
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients diagnosed with Lung cancer
Arm Type
Other
Arm Description
patients diagnosed with Lung cancer and Thoracic radiotherapy
Intervention Type
Drug
Intervention Name(s)
Perfluorinated Gas/Oxygen Mixture
Other Intervention Name(s)
Perfluorinated Propane Imaging
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Title
Proportion of study patients that successfully return for a re-assessment 19F MRI scan after completing radiotherapy.
Time Frame
6 weeks after completing RT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kolby Sidhu, MD
Organizational Affiliation
Duke University Medical Center, Department of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center - Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
19F Thoracic Radiotherapy for Lung Cancer
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