19F Thoracic Radiotherapy for Lung Cancer

Hal C Charles

Status and phase

Completed

Early Phase 1

Conditions

Lung Cancer

Treatments

Drug: Perfluorinated Gas/Oxygen Mixture

Study type

Interventional

Funder types

Other

Identifiers

NCT03315065

Pro00084472

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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