Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis

Summary

This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific imaging agent, known as 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease. This agent (18F-Fluciclovine) is investigational for the imaging of brain metastases.

Timeline

Start

2023-01-10

Primary completion

2030-01

Completion

2030-01

Publications

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• Background Jhaveri J, Chowdhary M, Zhang X, Press RH, Switchenko JM, Ferris MJ, Morgan TM, Roper J, Dhabaan A, Elder E, Eaton BR, Olson JJ, Curran WJ, Shu HG, Crocker IR, Patel KR. Does size matter? Investigating the optimal planning target volume margin for postoperative stereotactic radiosurgery to resected brain metastases. J Neurosurg. 2019 Mar 1;130(3):797-803. doi: 10.3171/2017.9.JNS171735. Epub 2018 Apr 20.
• Background Gui C, Moore J, Grimm J, Kleinberg L, McNutt T, Shen C, Chen L, Bettegowda C, Lim M, Redmond KJ. Local recurrence patterns after postoperative stereotactic radiation surgery to resected brain metastases: A quantitative analysis to guide target delineation. Pract Radiat Oncol. 2018 Nov-Dec;8(6):388-396. doi: 10.1016/j.prro.2018.04.010. Epub 2018 Apr 26.
• Background Shi S, Sandhu N, Jin M, Wang E, Liu E, Jaoude JA, Schofield K, Zhang C, Gibbs IC, Hancock SL, Chang SD, Li G, Gephart MH, Pollom EL, Soltys SG. Stereotactic Radiosurgery for Resected Brain Metastases: Does the Surgical Corridor Need to be Targeted? Pract Radiat Oncol. 2020 Sep-Oct;10(5):e363-e371. doi: 10.1016/j.prro.2020.04.009. Epub 2020 May 16.
• Background Soliman H, Ruschin M, Angelov L, Brown PD, Chiang VLS, Kirkpatrick JP, Lo SS, Mahajan A, Oh KS, Sheehan JP, Soltys SG, Sahgal A. Consensus Contouring Guidelines for Postoperative Completely Resected Cavity Stereotactic Radiosurgery for Brain Metastases. Int J Radiat Oncol Biol Phys. 2018 Feb 1;100(2):436-442. doi: 10.1016/j.ijrobp.2017.09.047. Epub 2017 Oct 4.
• Background Galldiks N, Langen KJ. Amino acid PET in neuro-oncology: applications in the clinic. Expert Rev Anticancer Ther. 2017 May;17(5):395-397. doi: 10.1080/14737140.2017.1302799. Epub 2017 Mar 11. No abstract available.
• Background Albert NL, Weller M, Suchorska B, Galldiks N, Soffietti R, Kim MM, la Fougere C, Pope W, Law I, Arbizu J, Chamberlain MC, Vogelbaum M, Ellingson BM, Tonn JC. Response Assessment in Neuro-Oncology working group and European Association for Neuro-Oncology recommendations for the clinical use of PET imaging in gliomas. Neuro Oncol. 2016 Sep;18(9):1199-208. doi: 10.1093/neuonc/now058. Epub 2016 Apr 21.
• Background Okudaira H, Shikano N, Nishii R, Miyagi T, Yoshimoto M, Kobayashi M, Ohe K, Nakanishi T, Tamai I, Namiki M, Kawai K. Putative transport mechanism and intracellular fate of trans-1-amino-3-18F-fluorocyclobutanecarboxylic acid in human prostate cancer. J Nucl Med. 2011 May;52(5):822-9. doi: 10.2967/jnumed.110.086074.
• Background Oka S, Okudaira H, Yoshida Y, Schuster DM, Goodman MM, Shirakami Y. Transport mechanisms of trans-1-amino-3-fluoro[1-(14)C]cyclobutanecarboxylic acid in prostate cancer cells. Nucl Med Biol. 2012 Jan;39(1):109-19. doi: 10.1016/j.nucmedbio.2011.06.008. Epub 2011 Sep 29.
• Background Ono M, Oka S, Okudaira H, Schuster DM, Goodman MM, Kawai K, Shirakami Y. Comparative evaluation of transport mechanisms of trans-1-amino-3-[(1)(8)F]fluorocyclobutanecarboxylic acid and L-[methyl-(1)(1)C]methionine in human glioma cell lines. Brain Res. 2013 Oct 16;1535:24-37. doi: 10.1016/j.brainres.2013.08.037. Epub 2013 Aug 27.
• Background Doi Y, Kanagawa M, Maya Y, Tanaka A, Oka S, Nakata N, Toyama M, Matsumoto H, Shirakami Y. Evaluation of trans-1-amino-3-18F-fluorocyclobutanecarboxylic acid accumulation in low-grade glioma in chemically induced rat models: PET and autoradiography compared with morphological images and histopathological findings. Nucl Med Biol. 2015 Aug;42(8):664-72. doi: 10.1016/j.nucmedbio.2015.04.008. Epub 2015 May 7.
• Background Sasajima T, Ono T, Shimada N, Doi Y, Oka S, Kanagawa M, Baden A, Mizoi K. Trans-1-amino-3-18F-fluorocyclobutanecarboxylic acid (anti-18F-FACBC) is a feasible alternative to 11C-methyl-L-methionine and magnetic resonance imaging for monitoring treatment response in gliomas. Nucl Med Biol. 2013 Aug;40(6):808-15. doi: 10.1016/j.nucmedbio.2013.04.007. Epub 2013 May 21.
• Background Oka S, Okudaira H, Ono M, Schuster DM, Goodman MM, Kawai K, Shirakami Y. Differences in transport mechanisms of trans-1-amino-3-[18F]fluorocyclobutanecarboxylic acid in inflammation, prostate cancer, and glioma cells: comparison with L-[methyl-11C]methionine and 2-deoxy-2-[18F]fluoro-D-glucose. Mol Imaging Biol. 2014 Jun;16(3):322-9. doi: 10.1007/s11307-013-0693-0.
• Background Parent EE, Patel D, Nye JA, Li Z, Olson JJ, Schuster DM, Goodman MM. [18F]-Fluciclovine PET discrimination of recurrent intracranial metastatic disease from radiation necrosis. EJNMMI Res. 2020 Dec 7;10(1):148. doi: 10.1186/s13550-020-00739-6.
• Background Kondo A, Ishii H, Aoki S, Suzuki M, Nagasawa H, Kubota K, Minamimoto R, Arakawa A, Tominaga M, Arai H. Phase IIa clinical study of [18F]fluciclovine: efficacy and safety of a new PET tracer for brain tumors. Ann Nucl Med. 2016 Nov;30(9):608-618. doi: 10.1007/s12149-016-1102-y. Epub 2016 Jul 14.
• Background Wakabayashi T, Iuchi T, Tsuyuguchi N, Nishikawa R, Arakawa Y, Sasayama T, Miyake K, Nariai T, Narita Y, Hashimoto N, Okuda O, Matsuda H, Kubota K, Ito K, Nakazato Y, Kubomura K. Diagnostic Performance and Safety of Positron Emission Tomography Using 18F-Fluciclovine in Patients with Clinically Suspected High- or Low-grade Gliomas: A Multicenter Phase IIb Trial. Asia Ocean J Nucl Med Biol. 2017 Winter;5(1):10-21. doi: 10.22038/aojnmb.2016.7869.
• Background Parent EE, Benayoun M, Ibeanu I, Olson JJ, Hadjipanayis CG, Brat DJ, Adhikarla V, Nye J, Schuster DM, Goodman MM. [18F]Fluciclovine PET discrimination between high- and low-grade gliomas. EJNMMI Res. 2018 Jul 25;8(1):67. doi: 10.1186/s13550-018-0415-3.
• Background Tsuyuguchi N, Terakawa Y, Uda T, Nakajo K, Kanemura Y. Diagnosis of Brain Tumors Using Amino Acid Transport PET Imaging with 18F-fluciclovine: A Comparative Study with L-methyl-11C-methionine PET Imaging. Asia Ocean J Nucl Med Biol. 2017 Spring;5(2):85-94. doi: 10.22038/aojnmb.2017.8843.
• Background Wakabayashi T, Hirose Y, Miyake K, Arakawa Y, Kagawa N, Nariai T, Narita Y, Nishikawa R, Tsuyuguchi N, Fukami T, Sasaki H, Sasayama T, Kondo A, Iuchi T, Matsuda H, Kubota K, Minamimoto R, Terauchi T, Nakazato Y, Kubomura K, Wada M. Determining the extent of tumor resection at surgical planning with 18F-fluciclovine PET/CT in patients with suspected glioma: multicenter phase III trials. Ann Nucl Med. 2021 Dec;35(12):1279-1292. doi: 10.1007/s12149-021-01670-z. Epub 2021 Aug 18.
• Background Gondi V, Bradley K, Mehta M, Howard A, Khuntia D, Ritter M, Tome W. Impact of hybrid fluorodeoxyglucose positron-emission tomography/computed tomography on radiotherapy planning in esophageal and non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):187-95. doi: 10.1016/j.ijrobp.2006.09.033.

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