Clinical trial NCT02528942: Feasibility Study Incorporating Lung Function Imaging Into Radiation Therapy for Lung Cancer Patients
Official title: Early Phase Clinical Trial Incorporating Lung Function Imaging Into Radiation Therapy for Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Lung Cancer
Keywords: Lung cancer
Radiation therapy
4DCT-ventilation imaging
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-08-19
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study is in the field of thoracic radiation oncology where radiation therapy is used to treat lung cancer. The primary objective of the early phase clinical trial will be to evaluate the safety of performing functional avoidance radiation therapy for lung cancer patients using 4D computed tomography (4DCT) ventilation imaging.

Detailed description: This study plans to learn more about radiation therapy. Radiation therapy is one of the main treatments used to treat lung cancer. One of the known side effects of this radiation therapy is scarring of the lungs and reduced lung function that can result in shortness of breath. At this time the radiation treatment plan does not take into account differences in lung function between one part of the lung and another. Studies have shown that lung function can vary substantially throughout the lungs. This study aims to plan the radiation therapy to be away from the highest functioning portions of lungs while still delivering the intended radiation dose to the tumor. This study will allow researchers to determine whether taking lung function information into account when designing radiation treatment plans can protect lung function after radiation therapy.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of pathologically confirmed lung cancer by tumor biopsy and/or fine-need aspiration
2. Lung Cancer patients that will undergo definitive radiation therapy defined as 45-75 Gy as part of standard of care for their disease
3. 18 years of age or older
4. Signed informed consent
5. Planned curative intent chemotherapy, delivered concurrently or sequentially in combination with radiotherapy
6. The patient's 4DCT-ventilation image meets image heterogeneity criteria

Exclusion Criteria:

1. Patients receiving Stereotactic Body Radiation Therapy
2. Patient receiving palliative radiation therapy (defined as less than 45 Gy)

Primary outcomes:
measure: Radiation Safety (Rate of Grade 2 or Higher (Grade 2+) Radiation Pneumonitis as Defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) Scoring System
timeFrame: Up to 14 months
Secondary outcomes:
measure: Percentage of Patients Eligible for 4DCT-ventilation Functional Avoidance
timeFrame: Up to 14 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
Study officials:
affiliation: University of Colorado, Denver
name: Yevgeniy Vinogradskiy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Porter EM, Myziuk NK, Quinn TJ, Lozano D, Peterson AB, Quach DM, Siddiqui ZA, Guerrero TM. Synthetic pulmonary perfusion images from 4DCT for functional avoidance using deep learning. Phys Med Biol. 2021 Aug 23;66(17). doi: 10.1088/1361-6560/ac16ec.