Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: 18F-Fluciclovine PET and Multiparametric MR Imaging

Summary: The purpose of the study is to investigate the use of the investigational agent Axumin (fluciclovine-F18) with PET/CT imaging in combination with standard MR imaging to detect remaining or recurrent glioma.

Detailed description: Methods:
  Patients with recurrent high grade glioma diagnosed on MRI and consenting to study protocol will undergo 18F-Fluciclovine PET/CT imaging. Surgery for recurrent brain tumor will follow standard of care treatment including as complete as possible tumor resection followed by histopathological analysis. Outcome evaluation will be analysis of tumor histology and imaging results, comparison of MRI, MRSI, and 18F-Fluciclovine imaging and relationship of imaging findings with histopathology and anatomical location of recurrent tumor.
  Study Objectives
  1. In this study, we will investigate the potential of 18F-fluciclovine to aid the visualization of residual or recurrent gliomas as depicted by 18F-Fluciclovine PET imaging compared to standard MRI sequences [T1 weighted imaging (T1WI) with contrast, diffusion weighted imaging (DWI), perfusion weighted imaging (PWI), T2 weighted fluid attenuated inversion recovery (T2 FLAIR)] using 3D image fusion.
  2. To assess the residual or recurrent of glioma as depicted by 3D short echo time MR spectroscopic imaging (MRSI) using metabolic tumor markers such as elevated choline, myo-Inositol and lipids and reduced N-acetyl-aspartate (NAA) compared to standard MRI sequences (T1WI with contrast, PWI, T2 FLAIR) using 3D image fusion before neurosurgical intervention.
  3. To spatially register the residual or recurrent glioma as depicted by 18F-Fluciclovine PET imaging with MR T1WI, DWI, PWI, and 3D MRSI to a) quantitate (SUVmax, SUVmean, ADCmean, rCBV, Cho, NAA, lipids, Cho/Cr, Cho/NAA) and correlate areas of PET+, T1WI+ and MRSI+ areas and b) characterize different metabolic profiles measured with MRSI in areas of glioma infiltration depicted by PET imaging and MRI.
  4. Biopsy and pathology confirmation of tumor vs treatment-induced necrosis in spatially registered areas of interest will be performed.
  Safety analysis Although 18F-Axumin™ is an FDA approved PET imaging agent for biological recurrent prostate cancer with extensive safety and toxicity data already documented, all patients will be monitored closely for adverse reactions after administration.

Eligibility: Inclusion Criteria:
  1. Patients evaluated for residual or recurrent gliomas after initial tumor surgery, external beam radiation and / or chemotherapy with temozolamide.
  2. Male and female
  3. Ages 18 to 70
  Exclusion Criteria:
  1. Patient diagnosis with glioma but before surgery, external beam radiation and /or chemotherapy with temozolamide.
  2. Women who were pregnant, breast feeding, or possibly pregnant.
  3. Patients with hepatic or renal dysfunction.
  4. Patients with MRI contraindications (i.e. pacemakers, non-MR compatible devices).
  5. Patients with a history of drug hypersensitivity to 18F-Fluciclovine.

Relevance to patient case: not relevant