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

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.

Inclusion Criteria:

- Patients who are offered radiotherapy using a 5-fraction stereotactic body radiation
therapy course, at the recommendation of the treating radiation oncologist

- Patients with early non-small cell lung carcinoma, or clinically-diagnosed early stage
lung cancer, or pulmonary metastases

- Patients with a limited (1-5) number of metastatic foci outside of the thorax who are
candidates for consolidative treatment with SBRT

- Patient with either a single focus or multiple foci (multi-isocentric planning) of
disease in the thorax amenable to SBRT with at least one focus with at least 1.5 cm or
larger in its largest diameter

- Patients who are planned to receive either chemotherapy, targeted therapy,
immunotherapy, or no additional cancer-directed drug therapy

Exclusion Criteria:

- Prior radiation therapy which would provide significant dose overlap with the planned
target volume(s) delivered within 30 days of enrollment or registration

- Major invasive surgical procedure occurring between the first treatment-eligible
PET/CT examination and end of radiotherapy that would affect the treatment target
region

- Patients with minimal FDG-avidity localized to the planned treatment target (e.g.
maximum standardized uptake value [SUV] < 4.0)

- Pregnancy