FLT-PET / MRI Brain Mets

Brain Metastases Clinical Trial

Official title:

Differentiating Radionecrosis From Tumour Progression Using Hybrid FLT-PET/MRI in Patients With Brain Metastases Treated With Stereotactic Radiosurgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04244019
• Other study ID #: 19-6056
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: March 2024

Study information

• Verified date: October 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis
• Radionecrosis

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radionecrosis (in patients who have previously recieved SRS Treatment for BrM)	Radionecrosis will be assessed by analyzing hybrid FLT-PET/MRI images.	24 Months
Secondary	Tumour Progression (in patients who have previously recieved SRS Treatment for BrM)	Tumour progression will be assessed by analyzing hybrid FLT-PET/MRI images.	24 Months