NCT03493789

Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy

A Pilot Study of FDG-PET Variability to Establish Biology-Guided Treatment Planning Feasibility for Stereotactic Body Radiation Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well fludeoxyglucose F-18 - positron emission tomography (PET) works in planning radiation therapy in participants with early non-small cell lung cancer, early stage lung cancer, or cancer that has spread to lungs from other parts of the body. Using PET in addition to the standard computed tomography to plan radiation therapy for cancer may help doctors to maximize the dose to the cancer and minimize the dose to normal tissues.

Detailed description

PRIMARY OBJECTIVE: To determine the maximum inter-fraction variability of fludeoxyglucose F-18 (18-F FDG)-PET activity of thoracic tumor treatment volumes through a 5-fraction stereotactic body radiation therapy (SBRT) course as it relates to the planning feasibility of emission-guided radiation therapy, or biologically-guided radiation therapy (BgRT). SECONDARY OBJECTIVES: I. To compare similar inter-fraction variability of FDG-PET activity for non-thoracic SBRT target volumes for the purpose of determining the feasibility of BgRT. II. To compare dosimetric endpoints for primary tumor coverage and dose to organs at risk between conventional SBRT planning and simulated BgRT, or emission-guided radiation therapy planning for thoracic and non-thoracic targets. III. To compare dosimetry for primary tumor coverage and dose to organs at risk between adaptive cone beam computed tomography (CT) planning, and simulated adaptive emission-guided radiation therapy (BgRT) planning for thoracic and non-thoracic targets. IV. To compare variability of 18-F FDG-PET in patients undergoing immunotherapy simultaneously during SBRT, or within 4 weeks of SBRT treatment with patients undergoing SBRT but not receiving immunotherapy. OUTLINE: Participants receive fludeoxyglucose F-18 intravenously (IV) and after 60 minutes undergo PET within 4 weeks of the first planned SBRT fraction, prior to the second planned fraction, and prior to the fifth planned fraction.

Conditions

• Stage I Lung Cancer
• Stage I Non-Small Cell Lung Cancer AJCC v7
• Stage IA Non-Small Cell Lung Carcinoma AJCC v7
• Stage IB Non-Small Cell Lung Carcinoma AJCC v7
• Stage II Lung Cancer
• Stage II Non-Small Cell Lung Cancer AJCC v7
• Stage IIA Non-Small Cell Lung Carcinoma AJCC v7
• Stage IIB Non-Small Cell Lung Carcinoma AJCC v7

Interventions

Type	Name	Description
DRUG	Fludeoxyglucose F-18	Given IV
PROCEDURE	Positron Emission Tomography (PET)	Undergo FDG-PET
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	Undergo SBRT

Timeline

• Start date: 2018-04-13
• Primary completion: 2019-03-19
• Completion: 2019-03-19
• First posted: 2018-04-11
• Last updated: 2023-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study