Brain MetastasesNCT06511323
Evaluation of Brain Metastases Treated With Stereotactic Radiotherapy Using Dynamic [18F]FDG PET
A study testing dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases in people with Brain Metastases, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Brain Metastases
- Being tested
- dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases
- Keywords
- Dynamic F-18 FDG PET,, Brain metastases, Stereotactic radiation, Radio-necrosis, Pseudo-progression
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic [18-FDG PET] scan post stereotactic radiation for brain metastasesDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Experimental | 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. Receives: Diagnostic Test: dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of dynamic PET
Diagnostic accuracy will be calculated and compared based on the index lesion.
Measured: 12-month follow-up.
Secondary outcomes (9)
Clinical outcomes
Clinical outcomes such as local recurrence.
Measured: 24-month follow-up
Clinical outcomes
CNS progression-free survival and overall survival will be analyzed
Measured: 24-month follow-up
Clinical outcomes
Factors impact on these outcomes will be explored.
Measured: 24-month follow-up
Diagnostic imaging outcomes
GMR-to-perfusion ratio.
Measured: 24-month follow-up
Diagnostic imaging outcomes
Blood-brain barrier permeability to glucose.
Measured: 24-month follow-up
Diagnostic imaging outcomes
Glucose Metabolic Rate.
Measured: 24-month follow-up
Diagnostic imaging outcomes
Magnetic resonance spectroscopy data.
Measured: 24-month follow-up
Diagnostic imaging outcomes
Other ancillary clinical data will be explored.
Measured: 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.
Measured: 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melody Qu, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511323
- Sponsor's protocol ID
- 124854
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Brain Metastases Treated With Stereotactic Radiotherapy Using Dynamic [18F]FDG PET
- ClinicalTrials.gov ID
- NCT06511323
- Acronym / sponsor ID
- 124854
- Conditions
- Brain Metastases
- Keywords
- Dynamic F-18 FDG PET,, Brain metastases, Stereotactic radiation, Radio-necrosis, Pseudo-progression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | Experimental | Diagnostic Test: dynamic [18-FDG PET] scan post stereotactic radiation for brain metastasesThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dynamic [18-FDG PET] scan post stereotactic radiation for brain metastasesat 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. | Diagnostic test | Observational |
Primary outcome
Diagnostic accuracy of dynamic PET
Time frame: 12-month follow-up.
Diagnostic accuracy will be calculated and compared based on the index lesion.
9 secondary outcomes
Clinical outcomes
Time frame: 24-month follow-up
Clinical outcomes
Time frame: 24-month follow-up
Clinical outcomes
Time frame: 24-month follow-up
Diagnostic imaging outcomes
Time frame: 24-month follow-up
Diagnostic imaging outcomes
Time frame: 24-month follow-up
Diagnostic imaging outcomes
Time frame: 24-month follow-up
Diagnostic imaging outcomes
Time frame: 24-month follow-up
Diagnostic imaging outcomes
Time frame: 24-month follow-up
Cost-effectiveness analysis
Time frame: 24-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases in people with Brain Metastases, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maureen Dougan (519 685 8500 ext. 35352, maureen.dougan@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of dynamic PET (time frame: 12-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.