Novel Lung Functional Imaging for Personalized Radiotherapy

University of California (UC) Davis

Status: Completed

Conditions: Lung Cancer

Treatments: Radiation: Ventilation image-guided radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02308709

CCRO030 (Other Identifier)

472677

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Ventilation image-guided radiotherapy

Experimental group

Description:

Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions

Treatment:

Radiation: Ventilation image-guided radiotherapy