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Clinical Trial · NCT06048094
18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery
Overview
This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.
Sponsor
Baptist Health South Florida
Phase
Phase 1
Contacts
Rupesh Kotecha, M.D. (PRINCIPAL_INVESTIGATOR)
Rupesh Kotecha, M.D. (CONTACT)
rupeshk@baptisthealth.net
(786) 596-2000
Kristy Reyes (CONTACT)
kristina.reyes@baptisthealth.net
(786) 596-2000
ClinicalTrials.gov
NCT06048094Drug / Compound
fluciclovine
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Amino Acid Transport
Ligand Class: Small Molecules
Eligibility
Inclusion
- Diagnosis of cancer with radiographic finding of brain metastasis
- Planned treatment with SRS as per the treating physician team
- Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension
- Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion
- Prior whole-brain radiation therapy
- Radiographic evidence of leptomeningeal disease
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