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

Phase 2

Recruiting

• Conditions: Brain Metastases; Brain Cancer
• Interventions: Drug: 18F-Fluciclovine

• Registration Number: NCT05554302
• Lead Sponsor: Baptist Health South Florida

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-26
• Study Start: 2023-01-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-18
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/CT, MRI	18F-Fluciclovine	All patients will obtain an 18F-Fluciclovine PET/CT scan in addition to the planning MRI at the time of SRS treatment (approximately 2-4 weeks after resection). The value of 18F-Fluciclovine in addition to structural information from the MRI will be analyzed. Patients will continue to undergo 18F-Fluciclovine in addition to MRI during routine follow-up to determine the ability of 18F-Fluciclovine PET/CT to identify areas at risk for marginal failure, monitor resection beds for tumor control, identify patients at risk for disease recurrence, and detect patterns of failure.

Primary Outcome Measures

Name	Time	Method
Change in conformality index of tumor target volume delineation	3 weeks, 6 and 12 months	The tumor target volume (post-operative cavity and any residual or recurrent disease) will be delineated by post-operative MRI only. A second target volume will be generated using the 18F-Fluciclovine PET-defined volume. The conformality index is calculated by comparing the PET-defined tumor volume with MRI-defined tumor volume. Non-overlapping and overlapping regions regions of PET tumor volume and MRI tumor volume will be used to calculate conformality indices.
Change in PET scan standardized uptake value (SUV) parameters	3 weeks, 6 and 12 months	The standardized uptake value (SUV) parameters of SUVpeak, SUVmean, and SUVmax will be measured to determine if they correlate tumor volume and can predict risk of recurrence.

Secondary Outcome Measures

Name	Time	Method
Time to local failure	1 year	Each lesion will be followed from pre-treatment PET to local failure or re-retreatment; death; 12 months from pre-treatment PET; lost-to follow-up, discontinuation, or withdrawal; or end of study. In the event that a patient has more than one study eligible lesion, the patient will discontinue follow up after all lesions progress, or will be censored as above. Death will be treated as a competing event.

Trial Locations

Locations (1)

Miami Cancer Institute at Baptist Health South Florida; 🇺🇸 Miami, Florida, United States