Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis

Launched by BAPTIST HEALTH SOUTH FLORIDA · Sep 21, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a special imaging technique using a substance called 18F-Fluciclovine to help doctors better understand and evaluate brain metastases, which are cancerous growths in the brain that have spread from other parts of the body. The study is for adults aged 18 and older who have had surgery to remove at least one brain metastasis and are scheduled to receive a type of targeted radiation therapy called stereotactic radiosurgery afterward. By using the 18F-Fluciclovine PET scan, the researchers hope to see if it can reveal more about the tumor than regular MRI scans and help detect any returning cancer.

To participate in this trial, you need to be an adult with a confirmed diagnosis of brain metastasis who is planning to undergo surgery and subsequent radiation treatment. There are some specific health criteria you must meet, such as not having had previous whole-brain radiation therapy and not being pregnant or breastfeeding at the time of the scan. If you decide to join, you may have the option to undergo a 18F-Fluciclovine PET scan before your surgery to help your doctors plan your treatment more effectively. As with any clinical trial, it’s important to discuss the potential risks and benefits with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. Performance status, Eastern Cooperative Oncology Group (ECOG) 0-3
• • 3. Radiographic diagnosis of brain metastasis
• • 4. Patient planned for surgical intervention for at least 1 metastasis
• • 5. 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).
• Exclusion Criteria:
• • 1. Prior anaphylactic reaction to 18F-Fluciclovine
• • 2. Evidence of leptomeningeal disease
• • 3. Prior whole-brain radiation therapy
• • 4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
• • 5. Pregnant at the expected time of 18F-fluciclovine administration
• • 6. 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.