18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

Study Overview
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Brief Summary
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This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.

Official Title
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18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)

Conditions
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Brain Metastases, Brain Metastases, Adult, Brain Cancer

Intervention / Treatment
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* Drug: 18F fluciclovine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cancer with radiographic finding of brain metastasis Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension Planned treatment with SRS as per the treating physician team Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET Exclusion Criteria: Prior anaphylactic reaction to 18F-fluciclovine Radiographic evidence of leptomeningeal disease Prior whole-brain radiation therapy Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker) Pregnant or positive serum pregnancy test within 14 days of registration Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 24 hours after the time of imaging is allowed. Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol and/or preclude informed consent* A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-Fluciclovine PET Imaging<br>Participants will undergo a 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). Then participants will undergo single-fraction SRS as standard of care (SOC). A second 18F-fluciclovine PET scan will be completed 8 weeks (± 2 weeks) after SRS. | Drug: 18F fluciclovine<br>* Participants will receive 5-mCi dose (± 20%) of 18F-fluciclovine intravenously as a bolus injection immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.<br>* Other names: (1r, 3r)-1-amino-3[18F] fluorocyclobutane-1-carboxylic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Standardized Uptake Value (SUV)-peak | Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVpeak will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected. | 8 weeks | 
| Change in SUVmean | Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmean will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected. | 8 weeks | 
| Change in SUVmax | Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmax will be calculated for the pre-SRS and post-SRS imaging studies, as well as the change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Control | Each lesion will be followed from pre-treatment PET to local failure or retreatment; death; lost-to follow-up, discontinuation, or withdrawal; or end of study. Local failure is defined as disease progression according to Response Assessment in Neuro-Oncology (RANO) criteria. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stereotactic radiosurgery, 18F-flucicloivine, PET imaging