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Brain MetastasesPhase 3REVELATENCT04410133

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

A Phase 3 study testing 18F fluciclovine in people with Brain Metastases, run by Blue Earth Diagnostics at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Metastases
What is being tested?
18F fluciclovine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
19 sitesUnited States
Study dates
26 Oct 2020to 5 Jun 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 1. Patients with a history of active hematological malignancy

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Medical College of Georgia, Augusta University

    Augusta, Georgia, 30912

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University Hospital Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

  • West Virgina University Cancer Institute

    Morgantown, West Virginia, 26506

  • Yale School of Medicine

    New Haven, Connecticut, 06519

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70131

  • NYU Langone Health

    New York, New York, 10016

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Center for Quantitative Cancer Imaging at Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of California, San Francisco

    San Francisco, California, 94118

  • John Wayne Cancer Institute at Providence St. John's Health Center

    Santa Monica, California, 90404

  • Washington University School of Medicine-Center for Clinical Imaging Research

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official 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

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

Being tested
18F fluciclovine
Keywords
Recurrent Brain Metastases, Diagnostic, Positron Emission Tomography (PET) Scan
Medical subject headings
Brain Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F fluciclovineDrug

    Also called Axumin

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

Study groups in NCT04410133
Study groupRoleWhat they receive
PatientsExperimentalSingle intravenous administration of 18F fluciclovine for PET Scan
Receives: Drug: 18F fluciclovine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 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.

Secondary outcomes (16)

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

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

    Measured: 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.

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

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

    Measured: 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.

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

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

    Measured: 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.

  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

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

    Measured: 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.

  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

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

    Measured: 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.

  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

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

    Measured: 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.

  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

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

    Measured: 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.

  8. Clinical Usefulness

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

    Measured: Follow up through 6 months after PET scan.

  9. Clinical Usefulness

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

    Measured: Follow up through 6 months after PET scan.

  10. Clinical Usefulness

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

    Measured: Follow up through 6 months after PET scan.

  11. Inter-reader Reproducibility

    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.

    Measured: PET Scan Day 1

  12. Intra-reader Reproducibility

    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.

    Measured: PET Scan Day 1

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

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

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

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

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

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

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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2020
  2. Study start26 Oct 2020
  3. Primary completion5 Jun 2023
  4. Study completion5 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Positron Emission Tomography (PET) Imaging study
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04410133
Sponsor's protocol ID
BED-FLC-312
Acronym
REVELATE
Status last verified
Aug 2025
First submitted
27 May 2020
Last updated
28 Aug 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.

    PubMed 34081125

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 18F fluciclovine in people with Brain Metastases, run by Blue Earth Diagnostics at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04410133, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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