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Completed

NCT Number: NCT04410133

Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases

An open-label, single dose, single arm, prospective, multicenter Phase 3 study to establish the diagnostic performance of 18F fluciclovine positron emission tomography (PET) in detecting recurrent brain metastases after radiation therapy

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Disease Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is an acute deterioration
  • Previous history of solid tumor brain metastasis of any origin
  • Histopathological confirmation of the primary solid tumor or a metastatic site within 4 years
  • Previous radiation therapy of brain metastatic lesion(s)
  • A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis
  • Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for biopsy/neurosurgical intervention as standard of care (SoC) or clinical follow-up as SoC

Exclusion criteria

  • Patients with a history of active hematological malignancy

Treatment and study plan

18F fluciclovine

Drug

18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus

Other names: Axumin

Primary outcomes

  1. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level

    Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

    Subject-level PPA and NPA (equivalent to sensitivity and specificity, respectively) of 18F-fluciclovinePET in detecting recurrent brain metastases.

Secondary outcomes

  1. Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)

    Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

    Subject-level PPV and NPV of 18F-fluciclovine PET for detecting recurrent brain metastases

  2. Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)

    Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

    To assess lesion-level PPA & NPA diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.

  3. Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)

    Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

    To assess lesion-level PPV & NPV diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.

  4. Subject-level Positive Percent Agreement (PPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type

    Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

    Sub-group analyses of subject-level PPA & NPA of fluciclovine (18F) PET, according to primary tumor type.

  5. Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type

    Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

    Sub-group analyses of subject-level PPV & NPV of fluciclovine (18F) PET, according to primary tumor type.

  6. Subject-level Positive Percent Agreement (NPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy

    Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

    Sub-group analyses of subject-level PPA & NPA of fluciclovine (18F) PET, according to concurrent immunotherapy.

  7. Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy

    Time frame: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.

    Sub-group analyses of subject-level PPV & NPV of fluciclovine (18F) PET, according to Concurrent Immunotherapy.

  8. Clinical Usefulness

    Time frame: Follow up through 6 months after PET scan.

    Number of days taken by the site to establish presence/absence of metastasis by clinical follow-up.

  9. Clinical Usefulness

    Time frame: Follow up through 6 months after PET scan.

    Proportion of subjects with additional metastases identified on fluciclovine (18F) PET in addition to SoC brain MRI

  10. Clinical Usefulness

    Time frame: Follow up through 6 months after PET scan.

    Proportion of subjects whose prospective diagnostic management plan changed following fluciclovine (18F) PET.

  11. Inter-reader Reproducibility

    Time frame: PET Scan Day 1

    Pairwise comparisons of the central reads for the 3 readers (i.e. Reader 1 vs Reader 2, Reader 1 vs Reader 3, and Reader 2 vs Reader 3) at the subject-level. The percentage of results in agreement (i.e. Positive [1st reader] / Positive [2nd reader], Negative/Negative) is presented.

  12. Intra-reader Reproducibility

    Time frame: PET Scan Day 1

    Pairwise comparisons of the initial read vs re-read of a subset of PET scans for each reader at the subject-level. The percentage of results in agreement (i.e. Positive [initial read] / Positive [re-read], Negative/Negative) is presented.

  13. Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure

    Time frame: The vital signs collected between 5 to 60 minutes before and after the PET scan.

    Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.

  14. Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Heart Rate

    Time frame: The vital signs collected between 5 to 60 minutes before and after the PET scan.

    Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.

  15. Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate

    Time frame: The vital signs collected between 5 to 60 minutes before and after the PET scan.

    Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.

  16. Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature

    Time frame: The vital signs collected between 5 to 60 minutes before and after the PET scan.

    Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.

Sponsors and collaborators

Lead sponsor

Blue Earth Diagnostics

Industry

Collaborators

  • Precision For Medicine

Registry information

Official study title

An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy

Acronym: REVELATE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2020
Registry last updated
Aug 28, 2025

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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