Recruiting
Phase 1

18F-Fluciclovine

Sponsor:

Baptist Health South Florida

Code:

NCT06048094

Conditions

Brain Metastases

Brain Metastases, Adult

Brain Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F fluciclovine

Study Details

Brief summary:

This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.

Conditions

Brain Metastases

Brain Metastases, Adult

Brain Cancer

Study ID

NCT06048094

Start date

Apr 11, 2024

Status verified date

May, 2026

Completion date

May, 2033

Anticipated

Primary completion date

Jun, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of cancer with radiographic finding of brain metastasis
  • Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension
  • Planned treatment with SRS as per the treating physician team
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET

Exclusion Criteria:

  • Prior anaphylactic reaction to 18F-fluciclovine
  • Radiographic evidence of leptomeningeal disease
  • Prior whole-brain radiation therapy
  • Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)
  • Pregnant or positive serum pregnancy test within 14 days of registration
  • Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 24 hours after the time of imaging is allowed.
  • Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol and/or preclude informed consent\*

  • A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.

Study Design

Enrollment

46 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 18F-Fluciclovine PET Imaging

Participants will undergo a 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). Then participants will undergo single-fraction SRS as standard of care (SOC). A second 18F-fluciclovine PET scan will be completed 8 weeks (± 2 weeks) after SRS.

Interventions

18F fluciclovine

Participants will receive 5-mCi dose (± 20%) of 18F-fluciclovine intravenously as a bolus injection 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 Standardized Uptake Value (SUV)-peak [ Time Frame: 8 weeks ]
  • Change in SUVmean [ Time Frame: 8 weeks ]
  • Change in SUVmax [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Rupesh Kotecha, M.D.

(786) 596-2000RupeshK@baptisthealth.net

Kristy Reyes

(786) 596-2000Kristina.Reyes@baptisthealth.net

Locations

Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

Rupesh Kotecha, M.D.

786-596-2000RupeshK@baptisthealth.net

Kristy Reyes

(786) 596-2000Kristina.Reyes@baptisthealth.net

More Information

Sponsor

Baptist Health South Florida

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

  • stereotactic radiosurgery
  • 18F-flucicloivine
  • PET imaging

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 2026-05-20.