18F-Fluciclovine PET and Multiparametric MR Imaging
Ključne besede
Povzetek
Opis
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.
Datumi
| Nazadnje preverjeno: | 04/30/2020 |
| Prvič predloženo: | 04/18/2019 |
| Predviden vpis oddan: | 04/18/2019 |
| Prvič objavljeno: | 04/23/2019 |
| Zadnja posodobitev oddana: | 05/26/2020 |
| Zadnja posodobitev objavljena: | 05/28/2020 |
| Dejanski datum začetka študija: | 09/09/2019 |
| Predvideni datum primarnega zaključka: | 03/30/2021 |
| Predvideni datum zaključka študije: | 03/30/2021 |
Stanje ali bolezen
Intervencija / zdravljenje
Drug: Axumin (fluciclovine-F18) PET/CT scan
Faza
Skupine rok
| Roka | Intervencija / zdravljenje |
|---|---|
| Experimental: Axumin (fluciclovine-F18) PET/CT scan Axumin (fluciclovine-F18) PET/CT scan to evaluate possible glioma recurrence to help differentiate scar (fake recurrence) from true tumor recurrence | Drug: Axumin (fluciclovine-F18) PET/CT scan Comparison between PET/CT, MRI / MRS imaging, and biopsy histopathology. Data from each modality will be analyzed separately as described above to determine tumor recurrence and/or presence of radiation changes. Different metabolic profiles measured in areas of imaging changes and depicted by PET imaging will be characterized. Biopsy locations from stereotactic MRI data will be co-localized with PET/CT and MRSI to correlate biopsy histopathology with MRI+, MRSI+ and PET+ lesion data. |
Merila upravičenosti
| Starost, primerna za študij | 18 Years Za 18 Years |
| Spol, upravičen do študija | All |
| Sprejema zdrave prostovoljce | Da |
| Merila | 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. |
Izid
Primarni izidni ukrepi
1. 18F-Fluciclovine [2 years]
2. 3D short echo time MR spectroscopic imaging (MRSI) [2 years]
3. 18F-Fluciclovine PET imaging with MR T1WI, DWI, PWI, and 3D MRSI [2 years]
4. Biopsy and pathology [2 years]
