Clinical trial NCT05554302: Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis
Official title: Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Brain Metastases
Brain Cancer
Keywords: Brain metastases
Brain cancer
Stereotactic radiosurgery
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
Collaborators: name: Blue Earth Diagnostics
First posted: 2022-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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.

Primary outcomes:
measure: Change in conformality index of tumor target volume delineation
timeFrame: 3 weeks, 6 and 12 months
measure: Change in PET scan standardized uptake value (SUV) parameters
timeFrame: 3 weeks, 6 and 12 months
Secondary outcomes:
measure: Time to local failure
timeFrame: 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health South Florida
state: Florida
Study officials:
affiliation: Miami Cancer Institute/Baptist Health South Florida
name: Rupesh R Kotecha, M.D.
role: PRINCIPAL_INVESTIGATOR
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