Evaluation of Brain Metastases Treated With Stereotactic Radiotherapy Using Dynamic [18F]FDG PET

The purpose of this study is to evaluate the clinical usefulness of dynamic [18F]FDG PET imaging in assessing brain metastasis post stereotactic radiotherapy to separate true progression from the treatment-related changes.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Metastases
• Intervention / Treatment: Diagnostic test: dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases

Detailed Description

After being informed about the study and potential risk, all participants giving written informed consent will be screened to determine if participant being referred fits eligibility criteria for the study, under of the supervision of the radiation oncologist. If a participant agrees to participate in this study, they will receive three additional imaging sessions (the dynamic PET scan). The first session will occur prior to starting treatment; the second session will occur at about 10 weeks post treatment; the third session will occur at first concern of progression at treated lesions or 12 months post-treatment, whichever comes earlier. These scans will be scheduled in addition to the participant's regular follow-up scans and appointments.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maureen Dougan; Phone Number: 35352 519 685 8500; Email: maureen.dougan@sjhc.london.on.ca
• Study Contact Backup: Name: Melody Qu; Phone Number: 53025 519 685 8500; Email: melody.qu@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 or older.
• Willing and able to provide consent.
• ECOG 0-2.
• Life expectancy ≥12 months.
• Creatinine clearance ≥30 ml/min within 28 days prior to registration.
• At the discretion of the treating oncologist, it is believed that at least 1 lesion (or resection cavity) is best managed with SRS/SFR

Exclusion Criteria:

• Pregnant or nursing women.
• Men or women of childbearing potential who are unwilling to employ adequate contraception.
• Inability to complete a brain MRI.
• Known allergy to gadolinium.
• Inability to complete a PET scan.
• Uncontrolled diabetes mellitus.
• Primary germ cell tumour, primary CNS tumour, or lymphoma
• SRS/FSRT is no longer indicated for any BMs
• Must be able to read and write English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Observational; This is a prospective, single-arm, pilot diagnostic study to evaluate the diagnostic accuracy of using dynamic [18F]FDG PET in 70 patients with brain metastases managed with stereotactic radiosurgery(SRS)/fractionated stereotactic radiotherapy (FSRT). The study will include imaging assessments at baseline, at 10 weeks after treatment, and at first concern for progression or 12 months post-treatment, whichever comes earlier.

Diagnostic test: dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases; at baseline prior to stereotactic radiation, at 10 weeks after treatment, and at first concern for progression at treated lesion or 12 months post-treatment, whichever comes earlier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of dynamic PET	Diagnostic accuracy will be calculated and compared based on the index lesion.	12-month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes	Clinical outcomes such as local recurrence.	24-month follow-up
Clinical outcomes	CNS progression-free survival and overall survival will be analyzed	24-month follow-up
Clinical outcomes	Factors impact on these outcomes will be explored.	24-month follow-up
Diagnostic imaging outcomes	GMR-to-perfusion ratio.	24-month follow-up
Diagnostic imaging outcomes	Blood-brain barrier permeability to glucose.	24-month follow-up
Diagnostic imaging outcomes	Glucose Metabolic Rate.	24-month follow-up
Diagnostic imaging outcomes	Magnetic resonance spectroscopy data.	24-month follow-up
Diagnostic imaging outcomes	Other ancillary clinical data will be explored.	24-month follow-up
Cost-effectiveness analysis	A decision analysis model coupled with Markov model will be constructed to estimate the incremental cost-effectiveness ratio (ICER) of performing dynamic PET in this setting from the Canadian health-care system perspective.	24-month follow-up

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Brain metastases; Stereotactic radiation; Dynamic F-18 FDG PET,; Radio-necrosis; Pseudo-progression
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 124854

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No