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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06511323
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases

Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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.