FLT-PET / MRI Brain Mets

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Radionecrosis

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network

Toronto, Ontario, L4W4C2, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

18 years or older
Previously treated with SRS for BrM
New intracranial lesion with clinical and radiographic findings suspicious for either RN or tumour progression
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.
A negative serum pregnancy test within the two-week interval immediately prior to PET-MRI imaging for women of child-bearing age
Ability to provide written informed concern to participate in the study

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Radionecrosis (in patients who have previously received SRS Treatment for BrM)

Time frame: 24 Months

Radionecrosis will be assessed by analyzing hybrid FLT-PET/MRI images.

Secondary outcomes

Tumour Progression (in patients who have previously received SRS Treatment for BrM)

Time frame: 24 Months

Tumour progression will be assessed by analyzing hybrid FLT-PET/MRI images.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2027
Study completion: 2027
First posted: Jan 28, 2020
Registry last updated: Mar 5, 2026

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.

Published trials that share one or more normalized conditions with this study.

Recruiting