Clinical trial NCT03315065: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Lung Cancer
Keywords: thoracic Radiation therapy
Lung Function
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of study patients consented (maximum 8)in order to result in 5 patients successfully completing both 19F functional MR imaging data sets
timeFrame: 4 months
measure: Proportion of study patients that successfully return for a re-assessment 19F MRI scan after completing radiotherapy.
timeFrame: 6 weeks after completing RT
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center - Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University Medical Center, Department of Radiation Oncology
name: Kolby Sidhu, MD
role: PRINCIPAL_INVESTIGATOR
References: