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History of Changes for Study: NCT04244019
FLT-PET / MRI Brain Mets
Latest version (submitted October 6, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 24, 2020 None (earliest Version on record)
2 March 23, 2020 Study Status
3 August 13, 2020 Study Status
4 October 18, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
5 April 1, 2021 Study Status
6 October 4, 2021 Study Status
7 April 14, 2022 Study Status
8 October 6, 2022 Study Status
Comparison Format:

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Study NCT04244019
Submitted Date:  January 24, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 19-6056
Brief Title: FLT-PET / MRI Brain Mets
Official Title: Differentiating Radionecrosis From Tumour Progression Using Hybrid FLT-PET/MRI in Patients With Brain Metastases Treated With Stereotactic Radiosurgery.
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2020
Overall Status: Not yet recruiting
Study Start: February 12, 2020
Primary Completion: February 12, 2022 [Anticipated]
Study Completion: February 12, 2022 [Anticipated]
First Submitted: January 2, 2020
First Submitted that
Met QC Criteria:
January 24, 2020
First Posted: January 28, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
January 24, 2020
Last Update Posted: January 28, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University Health Network, Toronto
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.

Detailed Description:
Open or close this module Conditions
Conditions: Brain Metastases
Radionecrosis
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 10 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
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.
Sampling Method: Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers:
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. 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
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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