Metastatic Intracranial Malignant Neoplasm, Recurrent Intracranial Neoplasm
Conditions
Brief summary
This phase I trial studies the ability and amount of fluciclovine positron emission tomography (PET) imaging needed to recognize tumors that have come back (recurrence) after brain injury from radiation therapy (radionecrosis) in patients with intracranial disease that has spread to other places in the body (metastatic). F-18 fluciclovine is a radiotracer that works by accumulating in tumor cells, making it easier to detect tumors. The results of this study may also help investigators understand all the ways that F-18 fluciclovine may affect patients.
Detailed description
PRIMARY OBJECTIVE: I. To determine the static fluciclovine F18 (fluciclovine) PET imaging tumor-to-background ratios (TBRmax; TBRmean) which distinguish true tumor recurrence from radionecrosis in patients with intracranial metastatic disease previously treated with radiation therapy, and magnetic resonance imaging (MRI) findings suggesting recurrent disease, using histopathology as proof of disease. SECONDARY OBJECTIVES: I. To determine static fluciclovine PET standardized uptake value (SUV)peak, SUVmean values and metabolic tumor volumes (MTV) which distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease, using serial MRI as a surrogate marker of disease. II. To determine early dynamic fluciclovine PET time activity curve values which distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease, using histopathology or serial MRI as a marker of disease. III. To correlate the determined static fluciclovine PET SUVpeak, SUVmean, TBRmax, TBRmean, and MTV values with progression free survival. IV. In patients with true tumor progression, SUV values will be correlated with Ki67 staining on final pathology. OUTLINE: Patients receive fluciclovine intravenously (IV) and undergo brain dynamic PET/MRI imaging over 50 minutes. After completion of study, patients are followed up every 3 months for up to 1 year.
Interventions
OTHERFluciclovine F18
Given IV
RADIATIONDynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography
Undergo PET-MRI imaging
Sponsors
Blue Earth Diagnostics
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical evidence of intracranial metastatic disease which underwent radiation and who presents with MRI findings suspicious for recurrent disease and/or radionecrosis (namely the 'index lesion')
Exclusion criteria
* Contraindication to contrast enhanced MRI * Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (surgical, hormonal or double barrier, i.e. condom and diaphragm) * Inability to lie still for 50 minutes during fluciclovine PET-MRI imaging * Inability or refusal to consent * Allergy or anaphylaxis to any of the reagents used in this study * Inability or unwillingness to return for required visits and follow-up exams
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor-to-background ratios (TBR)max and TBRmean thresholds | Up to 4 weeks post study registration | Will be estimated to delineate tumor progression from radionecrosis for use in future studies. The optimal TBRmax and TBRmean thresholds will be chosen as the threshold with the best cutpoint/threshold during a Receiver Operating Characteristics analysis corresponding to the maximum area under the curve (AUC) value when both the sensitivity and specificity are greater than 85%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Static values for fluciclovine SUVmean that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease | Up to 4 weeks post study registration | Determined using serial MRI as a surrogate marker of disease. The optimal SUVmean values will be chosen as the threshold with the best cutpoint/threshold during a Receiver Operating Characteristics analysis corresponding to the maximum AUC value when both the sensitivity and specificity are greater than 85%. |
| Static values for fluciclovine PET standardized uptake value (SUV)peak that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease | Up to 4 weeks post study registration | Determined using serial MRI as a surrogate marker of disease.The optimal SUVpeak, SUVmean and metabolic tumor volumes (MTV) values will be chosen as the threshold with the best cutpoint/threshold during a Receiver Operating Characteristics analysis corresponding to the maximum AUC value when both the sensitivity and specificity are greater than 85%. |
| Static values for metabolic tumor volumes (MTV) that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease | Up to 4 weeks post study registration | Determined using serial MRI as a surrogate marker of disease. The optimal MTV values will be chosen as the threshold with the best cutpoint/threshold during a Receiver Operating Characteristics analysis corresponding to the maximum AUC value when both the sensitivity and specificity are greater than 85%. |
| Incidence of adverse events | Every 3 months up to 1 year | Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation of SUV values with Ki67 staining | Up to 4 weeks post study registration | In patients with true tumor progression, SUV values will be correlated with Ki67 staining on final pathology. Spearman correlation analysis will be performed to determine if a relationship exists between SUV values and Ki67 staining values in patients with tumor progression. |
| Correlation of static fluciclovine PET SUVpeak, SUVmean, TBRmax, TBRmean, and MTV values with progression free survival | Up to 1 year after completion of PET/MR imaging | Differences in progression free survival time between patient groups based on the determined thresholds will be analyzed via Kaplan-Meier methods. |
| Early dynamic fluciclovine PET time-activity curve values which distinguish true tumor recurrence from radionecrosis | Up to 4 weeks post study registration | Will be chosen as the threshold with the best cutpoint/threshold during a Receiver Operating Characteristics analysis corresponding to the maximum area under the curve (AUC) value when both the sensitivity and specificity are greater than 85%. |
Countries
United States
Outcome results
None listed