Clinical trial NCT04462419: 18F-fluciclovine PET/MRI Imaging for the Detection of Tumor Recurrence After Radiation Injury to the Brain
Official title: 18F-Fluciclovine PET Discrimination of Radiation Injury to the Brain
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic Intracranial Malignant Neoplasm
Recurrent Intracranial Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Blue Earth Diagnostics
First posted: 2020-07-08
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intracranial metastatic disease (brain tumor) that has been treated with radiation therapy.

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.

Eligibility 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

Primary outcomes:
measure: Tumor-to-background ratios (TBR)max and TBRmean thresholds
timeFrame: Up to 4 weeks post study registration
Secondary outcomes:
measure: 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
timeFrame: Up to 4 weeks post study registration
measure: Static values for fluciclovine SUVmean that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease
timeFrame: Up to 4 weeks post study registration
measure: Static values for metabolic tumor volumes (MTV) that distinguish true tumor recurrence from radionecrosis in patients with MRI findings suggesting recurrent disease
timeFrame: Up to 4 weeks post study registration
measure: Incidence of adverse events
timeFrame: Every 3 months up to 1 year
Other outcomes:
measure: Early dynamic fluciclovine PET time-activity curve values which distinguish true tumor recurrence from radionecrosis
timeFrame: Up to 4 weeks post study registration
measure: Correlation of static fluciclovine PET SUVpeak, SUVmean, TBRmax, TBRmean, and MTV values with progression free survival
timeFrame: Up to 1 year after completion of PET/MR imaging
measure: Correlation of SUV values with Ki67 staining
timeFrame: Up to 4 weeks post study registration
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Daniel M. Trifiletti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.