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18F-Fluciclovine PET Evaluation for Brain Metastasis After Stereotactic Radiosurgery

This study is testing if a special type of imaging, called 18F-Fluciclovine PET (positron emission tomography), can help doctors see how brain metastases (cancers that have spread to the brain) respond to treatment with stereotactic radiosurgery (SRS). You might be able to join if you are an adult with brain metastases that are 2 cm or smaller, and you are planning to have SRS. The study will look at changes in how much of the 18F-Fluciclovine is absorbed by the brain metastases after 8 weeks to see if this imaging can be a good way to measure treatment success or if the cancer is growing. The current recruitment status is unclear, and the study plans to enroll 46 participants.

Study design
This is a pilot imaging study involving 46 participants. It is designed to see if 18F-Fluciclovine PET can be used as a biomarker.
What's involved
Participants will receive an intravenous injection of 18F-Fluciclovine immediately before PET data collection, which will last up to 25 minutes. This will happen at least once, with measurements taken at 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 8 weeks after the intervention.

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NCT06048094

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Baptist Health South Florida
~46 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:18F fluciclovine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Standardized Uptake Value (SUV)-peak
Measured over 8 weeks
+2 more outcomes measured

Conditions

Brain Metastases
Brain Metastases, Adult
Brain Cancer

Explore related trials

Malignant Brain NeoplasmMetastatic Malignant Neoplasm in the Brain

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Rupesh Kotecha, M.D. · PRINCIPAL_INVESTIGATOR · Miami Cancer Institute at Baptist Health, Inc.

Who to contact

Rupesh Kotecha, M.D.
[email protected]
(786) 596-2000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Standardized Uptake Value (SUV)-peak8 weeks

    Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVpeak will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.

  • Change in SUVmean8 weeks

    Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmean will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.

  • Change in SUVmax8 weeks

    Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmax will be calculated for the pre-SRS and post-SRS imaging studies, as well as the change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.