Clinical trial NCT02308709: Novel Lung Functional Imaging for Personalized Radiotherapy
Official title: Novel Lung Functional Imaging for Personalized Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Radiotherapy
Pulmonary Functional Imaging
Computed Tomography (CT)
Image Registration
Functional Image-guided Radiotherapy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the safety and feasibility of personalized radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation imaging, which selectively avoids irradiating highly-functional lung regions.

Detailed description: In this clinical trial, the investigators will assess the safety and feasibility of 4D CT ventilation image-guided personalized radiotherapy. The investigators will deliver personalized radiotherapy treatments that selectively avoid irradiating highly-functional lung regions for lung cancer patients, and follow up patients to assess the safety and feasibility. The primary hypothesis to be tested is: 4D CT ventilation image-guided personalized radiotherapy can be delivered safely for lung cancer.

Eligibility criteria: Inclusion Criteria:

* Primary lung cancer or metastatic disease to the lungs to be treated with either conventionally-fractionated radiotherapy (CFRT) or hypo-fractionated stereotactic ablative radiotherapy (SABR).
* Age restriction and/or gender/ethnic restrictions: Patients must be ≥18 years of age. There are no gender or ethnic restrictions.
* Concurrent chemotherapy is allowed, but not required.
* Life expectancy with treatment should be ≥6 months in the estimation of the treating physicians.
* Zubrod performance status ≤2
* Adequate marrow and hepatic function defined as Hgb ≥8; platelets ≥100k; ANC≥1500; LFTs ≤2x upper limit of normal and creatinine ≤1.3 or creatinine clearance of ≥50
* Patient must be able to provide study specific informed consent prior to study entry.

Exclusion Criteria:

* Prior radiotherapy for thoracic cancer or other malignancy leading to any overlap of planned radiotherapy fields.
* For patients undergoing definitive CFRT, patients with distant metastatic disease are not eligible.
* For patients undergoing SABR, both early stage primary lung cancer patients and those with limited metastatic disease to the lungs are eligible; however, patients with oligometastatic disease should have a controlled primary and no more than one other involved organ system.
* Children (\<18 years of age), pregnant women, University of California employees or students, or prisoners will be excluded from this study.

Primary outcomes:
measure: Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy
timeFrame: 12 months
Secondary outcomes:
measure: Radiation Pneumonitis Graded by CTCAE v4.0
timeFrame: 2 years
measure: Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline and 6 months
measure: Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Tokihiro Yamamoto, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: