Study Summary
This trial is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS). 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 the imaging agent, 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.
- Metastatic Brain Tumors
- Cancer Brain Metastases
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: 1 year
Trial Safety
Safety Progress
Side Effects for
Trial Design
1 Treatment Group
PET/CT, MRI
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: PET/CT, MRI · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Soltys JS, Wilson SE. Directional sensitivity of velocity sense in the lumbar spine. J Appl Biomech. 2008 Aug;24(3):244-51.
- 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.
- 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.
- Albert, Nathalie L., Michael Weller, Bogdana Suchorska, Norbert Galldiks, Riccardo Soffietti, Michelle M. Kim, Christian la Fougère, et al.. 2016. “Response Assessment in Neuro-oncology Working Group and European Association for Neuro-oncology Recommendations for the Clinical Use of PET Imaging in Gliomas”. Neuro-oncology. Oxford University Press (OUP). doi:10.1093/neuonc/now058.
- Kondo, Akihide, Hisato Ishii, Shigeki Aoki, Masaru Suzuki, Hidekazu Nagasawa, Kazuo Kubota, Ryogo Minamimoto, Atsushi Arakawa, Masato Tominaga, and Hajime Arai. 2016. “Phase Iia Clinical Study of [18f]fluciclovine: Efficacy and Safety of a New PET Tracer for Brain Tumors”. Annals of Nuclear Medicine. Springer Science and Business Media LLC. doi:10.1007/s12149-016-1102-y.
- Ono M, Oka S, Okudaira H, Schuster DM, Goodman MM, Kawai K, Shirakami Y. Comparative evaluation of transport mechanisms of trans-1-amino-3-[¹⁸F]fluorocyclobutanecarboxylic acid and L-[methyl-¹¹C]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.
- Kotecha R, Gondi V, Ahluwalia MS, Brastianos PK, Mehta MP. Recent advances in managing brain metastasis. F1000Res. 2018 Nov 9;7. pii: F1000 Faculty Rev-1772. doi: 10.12688/f1000research.15903.1. eCollection 2018. Review.
- Oka, Shuntaro, Hiroyuki Okudaira, Masahiro Ono, David M. Schuster, Mark M. Goodman, Keiichi Kawai, and Yoshifumi Shirakami. 2013. “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”. Molecular Imaging and Biology. Springer Science and Business Media LLC. doi:10.1007/s11307-013-0693-0.
- Gondi V, Bradley K, Mehta M, Howard A, Khuntia D, Ritter M, Tomé 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.
- Choi HJ, Choi SK, Lim YJ. Radiosurgical techniques and clinical outcomes of gamma knife radiosurgery for brainstem arteriovenous malformations. J Korean Neurosurg Soc. 2012 Dec;52(6):534-40. doi: 10.3340/jkns.2012.52.6.534. Epub 2012 Dec 31.
- 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.
- 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 (18)F-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.
- 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.
- 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.
- Wakabayashi, Toshihiko, Toshihiko Iuchi, Naohiro Tsuyuguchi, Ryo Nishikawa, Yoshiki Arakawa, Takashi Sasayama, Keisuke Miyake, et al.. 2017. “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 Oceania Journal of Nuclear Medicine and Biology 5 (1). IR: Asia Oceania Federation of Nuclear Medicine & Biology. doi:10.22038/aojnmb.2016.7869.
- 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.
- Parent, Ephraim E., Marc Benayoun, Ijeoma Ibeanu, Jeffrey J. Olson, Constantinos G. Hadjipanayis, Daniel J. Brat, Vikram Adhikarla, Jonathon Nye, David M. Schuster, and Mark M. Goodman. 2018. “[18f]fluciclovine PET Discrimination Between High- and Low-grade Gliomas”. EJNMMI Research. Springer Science and Business Media LLC. doi:10.1186/s13550-018-0415-3.
- 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. 2018 Apr 20;130(3):797-803. doi: 10.3171/2017.9.JNS171735.
- Parent EE, Patel D, Nye JA, Li Z, Olson JJ, Schuster DM, Goodman MM. [(18)F]-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.
- 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.
- Kotecha R, Ahluwalia MS, Siomin V, McDermott MW. Surgery, Stereotactic Radiosurgery, and Systemic Therapy in the Management of Operable Brain Metastasis. Neurol Clin. 2022 May;40(2):421-436. doi: 10.1016/j.ncl.2021.11.002. Epub 2022 Mar 31. Review.
- 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.
- Tsuyuguchi, Naohiro, Yuzo Terakawa, Takehiro Uda, Kosuke Nakajo, and Yonehiro Kanemura. 2017. “Diagnosis of Brain Tumors Using Amino Acid Transport PET Imaging with 18F- Fluciclovine: A Comparison Study with L-methyl-11c-methionine PET Imaging”. Asia Oceania Journal of Nuclear Medicine and Biology, no. Online First (June). IR: Asia Oceania Federation of Nuclear Medicine & Biology. doi:10.22038/aojnmb.2017.8843.
- Kotecha R, Ahluwalia MS, Siomin V, McDermott MW. Surgery, Stereotactic Radiosurgery, and Systemic Therapy in the Management of Operable Brain Metastasis. Neurol Clin. 2022 May;40(2):421-436. doi: 10.1016/j.ncl.2021.11.002. Epub 2022 Mar 31.
- 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.
- Kotecha R, Gondi V, Ahluwalia MS, Brastianos PK, Mehta MP. Recent advances in managing brain metastasis. F1000Res. 2018 Nov 9;7:F1000 Faculty Rev-1772. doi: 10.12688/f1000research.15903.1. eCollection 2018.
- Soltys JS, Wilson SE. Directional sensitivity of velocity sense in the lumbar spine. J Appl Biomech. 2008 Aug;24(3):244-51. doi: 10.1123/jab.24.3.244.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2023. "Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05554302.
Frequently Asked Questions
Are PET/CT and MRI scans safe procedures for patients to undergo?
"Due to the Phase 2 clinical trial status, there is moderate assurance of safety but no efficacy evidence yet for PET/CT and MRI. Therefore, it has been given a score of 2 on our risk assessment scale." - Anonymous Online Contributor
Are there currently any opportunities to enroll in the clinical trial?
"According to data hosted on clinicialtrials.gov, the trial in question is not actively recruiting patients at this time - with its initial posting being December 1st 2022 and most recent update occurring November 8th 2022. Nonetheless, there are still 889 other clinical trials that remain open for enrollment presently." - Anonymous Online Contributor