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NCT Number: NCT06511323

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

dynamic [18-FDG PET] scan post stereotactic radiation for brain metastases

Diagnostic 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.

Primary outcomes

  1. Diagnostic accuracy of dynamic PET

    Time frame: 12-month follow-up.

    Diagnostic accuracy will be calculated and compared based on the index lesion.

Secondary outcomes

  1. Clinical outcomes

    Time frame: 24-month follow-up

    Clinical outcomes such as local recurrence.

  2. Clinical outcomes

    Time frame: 24-month follow-up

    CNS progression-free survival and overall survival will be analyzed

  3. Clinical outcomes

    Time frame: 24-month follow-up

    Factors impact on these outcomes will be explored.

  4. Diagnostic imaging outcomes

    Time frame: 24-month follow-up

    GMR-to-perfusion ratio.

  5. Diagnostic imaging outcomes

    Time frame: 24-month follow-up

    Blood-brain barrier permeability to glucose.

  6. Diagnostic imaging outcomes

    Time frame: 24-month follow-up

    Glucose Metabolic Rate.

  7. Diagnostic imaging outcomes

    Time frame: 24-month follow-up

    Magnetic resonance spectroscopy data.

  8. Diagnostic imaging outcomes

    Time frame: 24-month follow-up

    Other ancillary clinical data will be explored.

  9. Cost-effectiveness analysis

    Time frame: 24-month follow-up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maureen Dougan

CONTACT

[email protected]

519 685 8500 ext. 35352

Melody Qu

CONTACT

[email protected]

519 685 8500 ext. 53025

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

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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