Using FLT-PET/MRI to differentiate between radionecrosis and tumor progression in brain metastases
Differentiating Radionecrosis From Tumour Progression Using Hybrid FLT-PET/MRI in Patients With Brain Metastases Treated With Stereotactic Radiosurgery.
This study is testing a new type of scan to help doctors tell the difference between brain damage from radiation and new tumor growth in patients who have had previous brain surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04244019 on ClinicalTrials.gov |
What this trial studies
This observational study aims to improve the diagnosis of brain metastases complications by utilizing a hybrid FLT-PET/MRI scan. It focuses on patients who have previously undergone stereotactic radiosurgery (SRS) and are presenting with new intracranial lesions that may indicate either radionecrosis or tumor progression. The study seeks to gather data that can help distinguish between these two conditions without the need for invasive surgical procedures. By analyzing the imaging characteristics, the investigators hope to provide a non-invasive diagnostic tool for clinicians.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been treated with SRS for brain metastases and have new lesions suspicious for radionecrosis or tumor progression.
Not a fit: Patients with previous radiotherapy to the intended treatment volume or those with active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of brain metastases complications, reducing the need for unnecessary surgeries.
How similar studies have performed: While the approach of using hybrid imaging is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.