Recruiting
Phase 1

18F-Fluciclovine

Sponsor:

Baptist Health South Florida

Code:

NCT04689048

Conditions

Brain Metastases, Adult

Brain Metastases

Brain Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F fluciclovine

Study Details

Brief summary:

The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.

Conditions

Brain Metastases, Adult

Brain Metastases

Brain Cancer

Study ID

NCT04689048

Start date

Apr 4, 2022

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female, age ≥18 years
2. Performance status, Eastern Cooperative Oncology Group 0-2
3. Confirmed diagnosis of brain metastases with at least one untreated lesion >2 cm in maximum diameter
4. Plan for SSRS per the treating team
5. For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
6. For females of reproductive potential: use of highly effective 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 positron emission tomography/computerized tomography

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. Females pregnant at the expected time of 18F-fluciclovine administration
6. Females who are 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
7. Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: PET/CT, MRI

In total, three 18F-fluciclovine PET/CT brain scans (pre-, interim-, and post-treatment) will be performed according to the study calendar. Generic name is Axumin and will be administered as an intravenous bolus. May administer diluted or undiluted. The maximum volume of undiluted 18F-fluciclovine is 5 mL. After administration, flush with normal saline to ensure full delivery of the dose.

Interventions

18F fluciclovine

Patients will receive a standard 5 millicuries dose 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.

Primary outcome measure

  • Change in sensitivity for PET/CT [ Time Frame: through study completion, an average of 1 year ]
  • Change in sensitivity for MRI [ Time Frame: through study completion, an average of 1 year ]
  • Change in the standardized uptake value (SUV) parameters [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Locations

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

More Information

Sponsor

Baptist Health South Florida

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • brain
  • brain metastases
  • brain metastases, adult
  • brain cancer
  • Stereotactic Radiosurgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baptist Health South Florida on 2026-04-22.