19F Thoracic Radiotherapy for Lung Cancer

Early Phase 1

Completed

• Conditions: Lung Cancer
• Interventions: Drug: Perfluorinated Gas/Oxygen Mixture

• Registration Number: NCT03315065
• Lead Sponsor: Hal C Charles

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.

Study Timeline

• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-19
• Study Start: 2018-02-16
• Primary Completion: 2019-06-25
• Study Completion: 2019-06-25
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with Lung cancer	Perfluorinated Gas/Oxygen Mixture	patients diagnosed with Lung cancer and Thoracic radiotherapy

Primary Outcome Measures

Name	Time	Method
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
Proportion of study patients that successfully return for a re-assessment 19F MRI scan after completing radiotherapy.	6 weeks after completing RT

Trial Locations

Locations (1)

Duke University Medical Center - Cancer Center; 🇺🇸 Durham, North Carolina, United States