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Completed

NCT Number: NCT03493789

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

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.

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Key information

Conditions

Stage I Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms 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 Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fludeoxyglucose F-18

Drug

Given IV

Other names: 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose

Positron Emission Tomography (PET)

Procedure

Undergo FDG-PET

Other names: Medical imaging, positron emission tomography, PET scan, Positron emission tomography scan, Proton magnetic resonance spectroscopic imaging

Stereotactic Body Radiation Therapy (SBRT)

Radiation

Undergo SBRT

Other names: SABR, Stereotactic ablative body radiation therapy

Primary outcomes

  1. Change in metabolic tumor volumes measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of thoracic stereotactic body radiation therapy (SBRT) target volumes

    Time frame: Up to 6 weeks from study start

    Metabolic tumor volumes across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients and for every tumor treated with SBRT.

  2. Change in total lesion glycolysis values measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of thoracic stereotactic body radiation therapy (SBRT) target volumes

    Time frame: Up to 6 weeks from study start

    Total lesion glycolysis values across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients and for every tumor treated with SBRT.

Secondary outcomes

  1. Change in metabolic tumor volumes measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of non-thoracic stereotactic body radiation therapy (SBRT) target volumes

    Time frame: Up to 6 weeks from study start

    Metabolic tumor volumes across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients.

  2. Change in total lesion glycolysis values measuring inter-fraction variability of fludeoxyglucose F-18-PET (FDG) - positron emission tomography (PET) activity of non-thoracic stereotactic body radiation therapy (SBRT) target volumes

    Time frame: Up to 6 weeks from study start

    Total lesion glycolysis values across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
  • RefleXion Medical

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2018
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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