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NCT Number: NCT06048094

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

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.

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Key information

Conditions

Brain Metastases Brain Cancer Brain Diseases Brain Metastases, Adult 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

  • 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.

Treatment and study plan

18F fluciclovine

Drug

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.

Other names: Axumin, 18F-FACBC, (1r, 3r)-1-amino-3[18F] fluorocyclobutane-1-carboxylic acid

Primary outcomes

  1. Change in Standardized Uptake Value (SUV)-peak

    Time frame: 8 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.

  2. Change in SUVmean

    Time frame: 8 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.

  3. Change in SUVmax

    Time frame: 8 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.

Secondary outcomes

  1. Tumor Control

    Time frame: 12 months

    Each lesion will be followed from pre-treatment PET to local failure or retreatment; death; lost-to follow-up, discontinuation, or withdrawal; or end of study. Local failure is defined as disease progression according to Response Assessment in Neuro-Oncology (RANO) criteria.

Study contacts

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

Kristy Reyes

CONTACT

[email protected]

(786) 596-2000

Rupesh Kotecha, M.D.

CONTACT

[email protected]

(786) 596-2000

Sponsors and collaborators

Lead sponsor

Baptist Health South Florida

Other

Collaborators

  • Blue Earth Diagnostics

Registry information

Official study title

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

Acronym: FACILITATE

Important dates

Study start
2024
Primary completion
2032
Study completion
2033
First posted
Sep 21, 2023
Registry last updated
May 20, 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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