Fluorine F18 Fluciclovine and Fluorine F 18 Fluorothymidine PET / CT in Diagnosing Patients with High-Grade Brain Tumors

Status: Active

Description

This phase II trial studies how well fluorine f18 fluciclovine and fluorine f18 fluorothymidine PET / CT work in diagnosing patients with high-grade brain tumors. Diagnostic procedures, such as f18 fluciclovine and fluorine f18 fluorothymidine positron-emission tomography (PET) / computed tomography (CT), may help find and diagnose high-grade brain tumors and find out how far the disease has spread.

Eligibility Criteria

Inclusion Criteria

  • Two adult patient groups will be eligible for inclusion in this study: * Group A: Patients where there is compelling evidence, based on the MRI and/or CT imaging, that a high-grade primary brain tumor is present; pathologic confirmation will occur with biopsy or surgery; patients whose tumor is felt to be inoperable and a biopsy is performed but no surgery; patients with a newly diagnosed primary malignant brain tumor (World Health Organization [WHO] grade III or IV) who will be receiving chemoradiation and who either did not undergo surgical resection or underwent incomplete resection with residual tumor >= 1.0 cm in greatest diameter by contrast MRI postoperatively * Group B: Patients with pathologically proven malignant brain tumor (WHO grade III or IV glial-based tumors) who have undergone chemoradiation and have MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression) within 6 months from the time of completion of chemoradiation
  • Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to have clinical endpoints and the results of histopathologic tissue analysis (when tissue becomes available from routine care) entered into a research database
  • All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
  • Determination of pregnancy status: Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to each set of [18F]FLT and [18F] Fluciclovine PET scans; a negative test will be necessary for such patients to undergo research PET imaging
  • Pre-imaging laboratory tests must be performed within 28 days prior to the [18F] FLT imaging procedure; these must be less than 4.0 times below or above the upper or lower limit range for the respective laboratory test for entry into the study (unless clinically not relevant); in those instances where a laboratory value is outside of this range, then such a patient will be ineligible for enrollment unless at the discretion of the principal investigator (PI) the abnormal lab value is of no clinical significance to the safety or integrity of the study results; for follow-up scanning sessions after therapy has been instituted, laboratory testing will also be required due to the use of [18F] FLT; the patients have brain tumors and will have received chemoradiation; therefore, many routine laboratory tests may not be within the typical normal range; as such, a factor of 4.0 times above or below the upper or lower value for the normal range for any laboratory test will also be used to determine the acceptable range for the 2nd and possibly 3rd imaging time points (unless clinically not relevant as explained above); the baseline laboratory testing will include liver enzymes (alanine transaminase [ALT], aspartate aminotransferase [AST]), bilirubin (total), serum electrolytes, complete blood count (CBC) with platelets, prothrombin time, partial thromboplastin time, blood urea nitrogen (BUN), and creatinine; for those patients receiving coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed 6 times the upper limit of the normal range

Exclusion Criteria

  • Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals; patients with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator’s discretion
  • Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to each set of multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile
  • Adult patients who require monitored anesthesia for PET scanning
  • Patients who are too claustrophobic to undergo PET scanning
  • Known human immunodeficiency virus (HIV) positive patients due to the previous toxicity noted with [18F] FLT in this patient group

Locations & Contacts

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: John M. Hoffman
Phone: 801-585-0255

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Define the semi-quantitative change in fluorine F 18 fluorothymidine ([18F] FLT) and fluorine F18 fluciclovine ([18F] Fluciclovine) uptake which is consistent with response based on standard brain tumor response criteria.

II. Define the semi-quantitative change in [18F] FLT and/or [18F] Fluciclovine uptake which predicts time to progression and overall survival.

III. Assess the ability of [18F] FLT or [18F] Fluciclovine alone or together to predict true progression from pseudoprogression in patients with this clinical dilemma.

IV. To show that a 25% reduction in maximum standardized uptake value (SUVmax) or mean standardized uptake value (SUVmean) for each of the PET imaging tracers will be predictive of increased overall survival.

SECONDARY OBJECTIVES:

I. Assess the association between overall survival and change in each of the following quantitative markers for [18F] Fluciclovine and [18F] FLT: K1-k4, Knet and Ktrans, from baseline to post therapy.

II. Assess the association between progression free survival and change in each of the following quantitative markers for [18F] Fluciclovine and [18F] FLT: K1-k4, Knet and Ktrans, from baseline to post therapy.

III. Assess the ability of [18F] FLT and/or [18F] Fluciclovine alone or together to predict true progression from pseudoprogression in patients with this clinical dilemma.

IV. A 25% reduction in SUVmax or SUVmean for each of the PET imaging tracers will be more predictive of overall survival than the current magnetic resonance imaging (MRI) based response criteria.

V. A 25% reduction in SUVmax or SUVmean for each of the PET imaging tracers will be more predictive of time to progression than the current MRI based response criteria.

OUTLINE:

Patients receive fluorine f18 fluciclovine intravenously (IV) over 60 seconds and undergo PET/CT. Patients also receive fluorine f18 fluorothymidine IV over 60 seconds and undergo PET/CT on a separate day. Patients undergo f18 fluciclovine and fluorine f18 fluorothymidine PET/CT at up to 3 time points: prior to any tumor-directed therapy, at the conclusions of the initial (around 6-8 weeks) chemoradiotherapy, and with MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression) within 6 months from the time of completion of chemoradiation.

After completion of study treatment, patients are followed up for 2 years.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Diagnostic

Lead Organization

Lead Organization
Huntsman Cancer Institute / University of Utah

Principal Investigator
John M. Hoffman

Trial IDs

Primary ID HCI104704
Secondary IDs NCI-2018-00328
Clinicaltrials.gov ID NCT03276676