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

Phase

Condition

Brain Metastases

Neoplasm Metastasis

Brain Cancer

Treatment

18F-Fluciclovine

Clinical Study ID

NCT05554302

2021-KOT-003

Ages > 18
All Genders

Study Summary

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.

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