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

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ClinicalTrials.gov Identifier: NCT04462419
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : June 14, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Metastatic Intracranial Malignant Neoplasm Recurrent Intracranial Neoplasm Radiation: Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography Other: Fluciclovine F18

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 18F-Fluciclovine PET Discrimination of Radiation Injury to the Brain
Actual Study Start Date : August 18, 2020
Estimated Primary Completion Date : August 15, 2025
Estimated Study Completion Date : August 15, 2026

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Undergo PET-MRI imaging
Other Names:
  • DCE-MRI with PET
  • DCE-MRI/PET

Other: Fluciclovine F18
Given IV
Other Names:
  • (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




Primary Outcome Measures :
  1. Tumor-to-background ratios (TBR)max and TBRmean thresholds [ Time Frame: Up to 13 months post-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 :
  1. 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 [ Time Frame: Up to 15 weeks post 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%.

  2. Static values for fluciclovine SUVmean that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease [ Time Frame: Up to 15 weeks post 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%.

  3. Static values for metabolic tumor volumes (MTV) that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease [ Time Frame: Up to 15 weeks post 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%.

  4. Incidence of adverse events [ Time Frame: Every 3 months up to 1 year ]
    Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.


Other Outcome Measures:
  1. Early dynamic fluciclovine PET time-activity curve values which distinguish true tumor recurrence from radionecrosis [ Time Frame: Up to 15 weeks post 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%.

  2. Correlation of static fluciclovine PET SUVpeak, SUVmean, TBRmax, TBRmean, and MTV values with progression free survival [ Time Frame: 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.

  3. Correlation of SUV values with Ki67 staining [ Time Frame: Up to 15 weeks post 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with intracranial metastatic disease (brain tumor) that has been treated with radiation therapy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04462419


Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224-9980
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Daniel Trifiletti, M.D.         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Daniel Trifiletti Mayo Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04462419    
Other Study ID Numbers: MC1975
NCI-2020-04564 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1975 ( Other Identifier: Mayo Clinic in Florida )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Brain Neoplasms
Radiation Injuries
Wounds and Injuries
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases