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NCT Number: NCT04689048

Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery

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.

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Key information

Conditions

Brain Metastases, Adult Brain Cancer Brain Diseases Brain Metastases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, age ≥18 years
  • Performance status, Eastern Cooperative Oncology Group 0-2
  • Confirmed diagnosis of brain metastases with at least one untreated lesion >2 cm in maximum diameter
  • Plan for SSRS per the treating team
  • For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
  • 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

  • Prior anaphylactic reaction to 18F-fluciclovine
  • Evidence of leptomeningeal disease
  • Prior whole-brain radiation therapy
  • Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
  • Females pregnant at the expected time of 18F-fluciclovine administration
  • 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
  • Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent

Treatment and study plan

18F fluciclovine

Drug

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.

Other names: Axumin

Primary outcomes

  1. Change in sensitivity for PET/CT

    Time frame: through study completion, an average of 1 year

    Calculate the sensitivity of pre-treatment 18F-fluciclovine PET/CT to identify brain metastases >2 cm treated with SSRS.

  2. Change in sensitivity for MRI

    Time frame: through study completion, an average of 1 year

    To calculate the sensitivity of pre-treatment contrast-enhanced MRI.

  3. Change in the standardized uptake value (SUV) parameters

    Time frame: through study completion, an average of 1 year

    To identify a change in the standardized uptake value (SUV) parameters (SUVpeak, SUVmean, and SUVmax) for the 18F-fluciclovine PET/CT scans.

Secondary outcomes

  1. Compare change of SUV metrics of 18F-fluciclovine PET

    Time frame: baseline

    To calculate the pre-, interim-, and post-treatment SUV metrics of 18F-fluciclovine PET uptake

  2. Compare change of SUV metrics of contrast-enhanced MRI

    Time frame: baseline

    To calculate the percent change in lesion volume on contrast-enhanced MRI (∆MRIvolume).

Study contacts

Contact information is provided by the study sponsor or research team.

Kristy Reyes

CONTACT

[email protected]

786-524-7311

Rupesh C Kotecha, MD

CONTACT

[email protected]

17865962000

Sponsors and collaborators

Lead sponsor

Baptist Health South Florida

Other

Collaborators

  • Blue Earth Diagnostics

Registry information

Official study title

Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 30, 2020
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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