FLT-PET / MRI Brain Mets

Differentiating Radionecrosis From Tumour Progression Using Hybrid FLT-PET/MRI in Patients With Brain Metastases Treated With Stereotactic Radiosurgery.

Brain metastasis (BrM) develops in approximately 40% of cancer patients. Stereotactic radiosurgery (SRS) is a form of radiotherapy that delivers high-dose per fraction to individual lesions that is commonly used to treat BrM.

Radionecrosis (RN) is an adverse event that occurs in approximately 10 - 25% of patients 6 - 24 months after treatment with SRS. Tumour progression may also occur due to local failure of treatment. Radionecrosis and tumour progression share very similar clinical features including vomiting, nausea, and focal neurologic findings.

Radionecrosis and tumour progression also share overlapping imaging characteristics. Due to their similarities, physicians need to perform a surgical resection to diagnose the complication. By using a hybrid FLT-PET/MRI scan, the investigators propose that this combination scan will provide robust data with which to differentiate between radionecrosis and tumour progression without the need for surgery. The investigators plan to conduct a single center feasibility study to investigate the potential in differentiating between SRS and tumour progression in patients, including those who may have previously undergone SRS for BrM, who are suspected to have either RN or tumour progression using hybrid FLT-PET/MRI imaging.

Study Overview

• Status: Active, not recruiting
• Conditions: Brain Metastases; Radionecrosis

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, L4W4C2
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients presenting after being treated with SRS with a new intracranial lesion with clinical and radiographic findings suspicious for either radionecrosis or tumour progression.

Description

Inclusion Criteria:

1. 18 years or older
2. Previously treated with SRS for BrM
3. New intracranial lesion with clinical and radiographic findings suspicious for either RN or tumour progression
4. May be planned surgical resection of the lesion in question. The determination that the lesion is appropriate for and may require surgical resection will be made by the multi-disciplinary brain metastasis team. Surgery is preferred but not required. If a patient is planned for surgery, the date does not need to be established and the patient does not need to have consented in order to be eligible for this study, however the imaging procedure will need to occur prior to the date of surgery.
5. A negative serum pregnancy test within the two-week interval immediately prior to PET-MRI imaging for women of child-bearing age
6. Ability to provide written informed concern to participate in the study

Exclusion Criteria:

1. Previous radiotherapy to the intended treatment volume
2. Active malignancy other than sarcoma
3. Inability to remain supine for at least 60 minutes
4. Pregnancy or breast feeding
5. Age <18 years
6. Failure to provide written informed consent
7. Contraindication for MRI as per current institutional guidelines

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radionecrosis (in patients who have previously received SRS Treatment for BrM)	Radionecrosis will be assessed by analyzing hybrid FLT-PET/MRI images.	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumour Progression (in patients who have previously received SRS Treatment for BrM)	Tumour progression will be assessed by analyzing hybrid FLT-PET/MRI images.	24 Months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 19-6056

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No