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

NCT06511323 | Not Yet Recruiting

• 1 other identifier: 124854
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Brain Metastases

Keywords

Dynamic F-18 FDG PET,; Brain metastases; Stereotactic radiation; Radio-necrosis; Pseudo-progression

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of dynamic PET

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

  12-month follow-up.

Secondary Outcomes (9)

• Clinical outcomes

  24-month follow-up

• Clinical outcomes

  24-month follow-up

• Clinical outcomes

  24-month follow-up

• Diagnostic imaging outcomes

  24-month follow-up

• Diagnostic imaging outcomes

  24-month follow-up

Study Arms (1)

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.

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

Interventions

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.

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Maureen Dougan

CONTACT

519 685 8500; maureen.dougan@sjhc.london.on.ca

Melody Qu

CONTACT

519 685 8500; melody.qu@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 19, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share