18F-fluciclovine PET/MRI Imaging for the Detection of Tumor Recurrence After Radiation Injury to the Brain

Active, not recruiting

• Conditions: Metastatic Intracranial Malignant Neoplasm; Recurrent Intracranial Neoplasm
• Interventions: Radiation: Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography; Other: Fluciclovine F18

• Registration Number: NCT04462419
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-08
• Study Start: 2020-08-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-08-15
• Study Completion: 2026-08-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 19

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')

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic (18F-fluciclovine, PET/MRI imaging)	Fluciclovine F18	Patients receive fluciclovine IV and undergo brain dynamic PET/MRI imaging over 50 minutes.
Diagnostic (18F-fluciclovine, PET/MRI imaging)	Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography	Patients receive fluciclovine IV and undergo brain dynamic PET/MRI imaging over 50 minutes.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States