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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
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date January 2, 2020
First Posted Date January 28, 2020
Last Update Posted Date April 15, 2022
Actual Study Start Date October 1, 2020
Estimated Primary Completion Date February 12, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 24, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 24, 2020)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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.
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 Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Brain Metastases
  • Radionecrosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 24, 2020)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 12, 2023
Estimated Primary Completion Date February 12, 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04244019
Other Study ID Numbers 19-6056
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party University Health Network, Toronto
Original Responsible Party Same as current
Current Study Sponsor University Health Network, Toronto
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account University Health Network, Toronto
Verification Date April 2022