19F Thoracic Radiotherapy for Lung Cancer

NCT ID: NCT03315065

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-16
• Study Completion Date: 2019-06-25

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients diagnosed with Lung cancer

patients diagnosed with Lung cancer and Thoracic radiotherapy

Group Type: OTHER

Perfluorinated Gas/Oxygen Mixture

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Perfluorinated Propane Imaging

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hal C Charles

OTHER

Sponsor Role: lead

Responsible Party

Hal C Charles

Associate Professor Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kolby Sidhu, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Medical Center, Department of Radiation Oncology

Locations

Duke University Medical Center - Cancer Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00084472

Identifier Type: -

Identifier Source: org_study_id