Phase
Condition
Neoplasm Metastasis
Brain Metastases
Astrocytoma
Treatment
18F-Fluciclovine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years
Performance status, Eastern Cooperative Oncology Group (ECOG) 0-3
Radiographic diagnosis of brain metastasis
Patient planned for surgical intervention for at least 1 metastasis
Patient planned for postoperative SRS
Male or female patients of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-Fluciclovine PET/CT. Highly effective and acceptable forms of contraception are:
Male condom plus spermicide
Cap plus spermicide
Diaphragm plus spermicide
Copper T
Progesterone T
Levonorgestrel-releasing intrauterine system (e.g., Mirena®)
Implants
Hormone shot or injection
Combined pill
Mini-pill
Patch
Postmenopausal people on the study (that will not need contraception) is defined as at least one of the following:
Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in thepostmenopausal range for women under 50
Radiation-induced oophorectomy with last menses > 1 year ago
Chemotherapy-induced menopause with >1 year interval since last menses
Surgical sterilization (bilateral oophorectomy or hysterectomy).
Exclusion
Exclusion Criteria:
Prior anaphylactic reaction to 18F-Fluciclovine
Evidence of leptomeningeal disease
Prior whole-brain radiation therapy
Contraindication to MRI (e.g., due to safety reasons, such as presence of apacemaker)
Pregnant at the expected time of 18F-fluciclovine administration
Expecting to be breastfeeding at the time of 18F-Fluciclovine and unwilling to stopbreast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after thetime of imaging is allowed.
Study Design
Connect with a study center
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida 33176
United StatesActive - Recruiting
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