What this study is
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.
What's being tested
- 18F-Fluciclovine
Intervention · DRUG
Patients will receive 5-mCi dose (+/- 20%) of 18F-Fluciclovine intravenously as a bolus injection. They will be required to fast for at least four hours prior to 18F-Fluciclovine injection. Patients will be positioned for PET/CT brain imaging and will be injected with 18F-Fluciclovine immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.
Study details
- Sponsor
- Baptist Health South Florida
- Conditions
- Brain Metastases · Brain Cancer
- Enrolling
- 20 people
- Starts
- 2023-01-10
- Est. completion
- 2030-01
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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 the postmenopausal 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).
You can't join if
- 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 a pacemaker)
- Pregnant at the expected time of 18F-fluciclovine administration
- Expecting to be breastfeeding at the time of 18F-Fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMiami Cancer Institute at Baptist Health South Florida
Miami, Florida, United States
- Rupesh Kotecha, MD · Contact786-527-7642RupeshK@baptisthealth.net
- Rupesh Kotecha, MD · Principal investigator
Recruiting
Study team
Sponsor
Baptist Health South Florida
Study ID 2021-KOT-003
Principal investigator
Rupesh R Kotecha, M.D.
Miami Cancer Institute/Baptist Health South Florida
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.