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FLT-PET / MRI Brain Mets

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT04244019
Collaborator
(none)
10
Enrollment
1
Location
28.4
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Oct 1, 2020
    Anticipated Primary Completion Date :
    Feb 12, 2023
    Anticipated Study Completion Date :
    Feb 12, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Radionecrosis (in patients who have previously recieved SRS Treatment for BrM) [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) [24 Months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Network Toronto Ontario Canada L4W4C2

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT04244019
    Other Study ID Numbers:
    • 19-6056
    First Posted:
    Jan 28, 2020
    Last Update Posted:
    Apr 15, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Brain Neoplasms

    Study Results

    No Results Posted as of Apr 15, 2022