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FLT-PET / MRI Brain Mets

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ClinicalTrials.gov Identifier: NCT04244019
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : October 7, 2022
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
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 2023
Estimated Study Completion Date : February 2023

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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. Planned surgical resection of the lesion in question. The determination that the lesion is appropriate for and requires surgical resection will be made by the multi-disciplinary brain metastasis team. The surgery 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

Information from the National Library of Medicine

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

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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, L4W4C2
Contact: David Shultz, MD    416 946 4501    david.shultz@rmp.uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04244019    
Other Study ID Numbers: 19-6056
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: October 7, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases