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

NCT04462419 | Terminated FDA Drug

• 3 other identifiers: MC1975NCI-2020-0456419-004459
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Intracranial Malignant Neoplasm; Recurrent Intracranial Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

• 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

• Incidence of adverse events

  Every 3 months up to 1 year

Other Outcomes (3)

• Early dynamic fluciclovine PET time-activity curve values which distinguish true tumor recurrence from radionecrosis

  Up to 4 weeks post study registration

• 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

• Correlation of SUV values with Ki67 staining

  Up to 4 weeks post study registration

Study Arms (1)

Diagnostic (18F-fluciclovine, PET/MRI imaging)

Patients receive fluciclovine IV and undergo brain dynamic PET/MRI imaging over 50 minutes.

Radiation: Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography; Other: Fluciclovine F18

Interventions

Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography RADIATION

Undergo PET-MRI imaging

Also known as: DCE-MRI with PET, DCE-MRI/PET

Diagnostic (18F-fluciclovine, PET/MRI imaging)

Fluciclovine F18 OTHER

Given IV

Also known as: (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC, Anti-(18f)FABC, Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid, Anti-[18F] FACBC, Axumin, Fluciclovine (18F), FLUCICLOVINE F-18, GE-148 (18F), GE-148 F-18

Diagnostic (18F-fluciclovine, PET/MRI imaging)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with intracranial metastatic disease (brain tumor) that has been treated with radiation therapy.

You may qualify if:

• 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')

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Publications (1)

• 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.

  PMID: 34081125 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; fluciclovine F-18

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Daniel M. Trifiletti, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 8, 2020
• Study Start: August 18, 2020
• Primary Completion: December 13, 2023
• Study Completion: November 13, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

US (1)