FLT-PET / MRI Brain Mets
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04244019|
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : April 15, 2022
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 who have previously undergone SRS for BrM who are suspected to have either RN or tumour progression using hybrid FLT-PET/MRI imaging.
|Condition or disease|
|Brain Metastases Radionecrosis|
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Differentiating Radionecrosis From Tumour Progression Using Hybrid FLT-PET/MRI in Patients With Brain Metastases Treated With Stereotactic Radiosurgery.|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||February 12, 2023|
|Estimated Study Completion Date :||February 12, 2023|
- Radionecrosis (in patients who have previously recieved SRS Treatment for BrM) [ Time Frame: 24 Months ]Radionecrosis will be assessed by analyzing hybrid FLT-PET/MRI images.
- Tumour Progression (in patients who have previously recieved SRS Treatment for BrM) [ Time Frame: 24 Months ]Tumour progression will be assessed by analyzing hybrid FLT-PET/MRI images.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04244019
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, L4W4C2|
|Contact: David Shultz, MD 416 946 4501 email@example.com|