19F Thoracic Radiotherapy for Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03315065
• Other study ID #: Pro00084472
• Status: Completed
• Phase: Early Phase 1
• Start date: February 16, 2018
• Est. completion date: June 25, 2019

Study information

• Verified date: July 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 25, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center - Cancer Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Hal C Charles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of study patients consented (maximum 8)in order to result in 5 patients successfully completing both 19F functional MR imaging data sets		4 months
Primary	Proportion of study patients that successfully return for a re-assessment 19F MRI scan after completing radiotherapy.		6 weeks after completing RT