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.
Conditions:
🦠 Brain Metastases 🦠 Brain Metastases, Adult 🦠 Brain Cancer
🗓️ Study Start (Actual) 11 April 2024
🗓️ Primary Completion (Estimated) May 2026
✅ Study Completion (Estimated) May 2027
👥 Enrollment (Estimated) 46
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Miami, Florida, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 September 2023
  • First Submitted that Met QC Criteria 15 September 2023
  • First Posted 21 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 April 2024
  • Last Update Posted 18 April 2024
  • Last Verified April 2024