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

July 15, 2024 updated by: Melody Qu, Lawson Health Research Institute
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 12-month follow-up.
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
Time Frame: 24-month follow-up
Clinical outcomes such as local recurrence.
24-month follow-up
Clinical outcomes
Time Frame: 24-month follow-up
CNS progression-free survival and overall survival will be analyzed
24-month follow-up
Clinical outcomes
Time Frame: 24-month follow-up
Factors impact on these outcomes will be explored.
24-month follow-up
Diagnostic imaging outcomes
Time Frame: 24-month follow-up
GMR-to-perfusion ratio.
24-month follow-up
Diagnostic imaging outcomes
Time Frame: 24-month follow-up
Blood-brain barrier permeability to glucose.
24-month follow-up
Diagnostic imaging outcomes
Time Frame: 24-month follow-up
Glucose Metabolic Rate.
24-month follow-up
Diagnostic imaging outcomes
Time Frame: 24-month follow-up
Magnetic resonance spectroscopy data.
24-month follow-up
Diagnostic imaging outcomes
Time Frame: 24-month follow-up
Other ancillary clinical data will be explored.
24-month follow-up
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.
24-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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