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.
Eligible Conditions
- Metastatic Brain Tumors
- Cancer Brain Metastases
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: 1 year
1 year
Time to local failure
Month 12
Positron-Emission Tomography
Change in conformality index of tumor target volume delineation
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
18F-Fluciclovine
8%Sepsis
8%Urinary tract infection
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
PET/CT, MRI
Drug
Experimental Group · 1 Intervention: 18F-Fluciclovine · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-Fluciclovine
2017
Completed Phase 2
~30
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Who is running the clinical trial?
Blue Earth DiagnosticsIndustry Sponsor
28 Previous Clinical Trials
2,591 Total Patients Enrolled
Baptist Health South FloridaLead Sponsor
45 Previous Clinical Trials
7,863 Total Patients Enrolled
Rupesh R Kotecha, M.D.Principal InvestigatorMiami Cancer Institute/Baptist Health South Florida
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are scheduled to have surgery to remove at least one metastasis.
You are scheduled to have a procedure called postoperative SRS (stereotactic radiosurgery).
References
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- 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.
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- 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.
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- 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
Unverified Answer
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
Unverified Answer