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

NCT ID: NCT03493789

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-13
• Study Completion Date: 2019-03-19

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (FDG-PET, SBRT)

Participants receive fludeoxyglucose F-18 IV and after 60 minutes undergo positron emission tomography (PET) within 4 weeks of the first planned stereotactic body radiation therapy (SBRT) fraction, prior to the second planned fraction, and prior to the fifth planned fraction.

Group Type: EXPERIMENTAL

Fludeoxyglucose F-18

Intervention Type: DRUG

Given IV

Positron Emission Tomography (PET)

Intervention Type: PROCEDURE

Undergo FDG-PET

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: RADIATION

Undergo SBRT

Interventions

Fludeoxyglucose F-18

Given IV

Intervention Type: DRUG

Positron Emission Tomography (PET)

Undergo FDG-PET

Intervention Type: PROCEDURE

Stereotactic Body Radiation Therapy (SBRT)

Undergo SBRT

Intervention Type: RADIATION

Other Intervention Names

18FDG; FDG; Fluorine-18 2-Fluoro-2-deoxy-D-Glucose; Medical imaging, positron emission tomography; PET scan; Positron emission tomography scan; Proton magnetic resonance spectroscopic imaging; SABR; Stereotactic ablative body radiation therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RefleXion Medical

INDUSTRY

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Kristin Higgins

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Higgins, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2018-00375

Identifier Type: REGISTRY

Identifier Source: secondary_id

RAD4267-17

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00101066

Identifier Type: -

Identifier Source: org_study_id