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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-04564 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| MC1975 | Other Identifier | Mayo Clinic in Florida | |
| 19-004459 | Other Identifier | Mayo Clinic Institutional Review Board |
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slow enrollment
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| Name | Class |
|---|---|
| Blue Earth Diagnostics | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (18F-fluciclovine, PET/MRI imaging) | Patients receive fluciclovine IV and undergo brain dynamic PET/MRI imaging over 50 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography | Radiation | Undergo PET-MRI imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor-to-background ratios (TBR)max and TBRmean thresholds | 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%. | Up to 4 weeks post study registration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| Early dynamic fluciclovine PET time-activity curve values which distinguish true tumor recurrence from radionecrosis | 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%. | Up to 4 weeks post study registration |
Inclusion Criteria:
Exclusion Criteria:
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Patients with intracranial metastatic disease (brain tumor) that has been treated with radiation therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel M. Trifiletti, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34081125 | Derived | Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Fluciclovine F18 | Other | Given IV |
|
|
| Up to 4 weeks post study registration |
| Static values for fluciclovine SUVmean that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease | 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%. | Up to 4 weeks post study registration |
| Static values for metabolic tumor volumes (MTV) that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease | 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%. | Up to 4 weeks post study registration |
| Incidence of adverse events | Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. | Every 3 months up to 1 year |
| Correlation of static fluciclovine PET SUVpeak, SUVmean, TBRmax, TBRmean, and MTV values with progression free survival | Differences in progression free survival time between patient groups based on the determined thresholds will be analyzed via Kaplan-Meier methods. | Up to 1 year after completion of PET/MR imaging |
| Correlation of SUV values with Ki67 staining | 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. | Up to 4 weeks post study registration |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| C117460 | fluciclovine F-18 |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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