Who is eligible for clinical trial NCT04244019?

Participants must meet protocol criteria for Brain Metastases. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04244019 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-03

FLT-PET / MRI Brain Mets (NCT04244019)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: University Health Network, Toronto

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (8 items).

Location: University Health Network — Toronto, Ontario

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University Health Network — Toronto, Ontario

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗