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

August 26, 2025 updated by: Blue Earth Diagnostics

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
    • California
      • San Francisco, California, United States, 94118
        • University of California, San Francisco
      • Santa Monica, California, United States, 90404
        • John Wayne Cancer Institute at Providence St. John's Health Center
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale School of Medicine
    • Florida
      • Miami, Florida, United States, 33176
        • Miami Cancer Institute at Baptist Health, Inc.
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia, Augusta University
    • Louisiana
      • New Orleans, Louisiana, United States, 70131
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Rogel Cancer Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine-Center for Clinical Imaging Research
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospital Cleveland
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Center for Quantitative Cancer Imaging at Huntsman Cancer Institute
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virgina University Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is an acute deterioration
  2. Previous history of solid tumor brain metastasis of any origin
  3. Histopathological confirmation of the primary solid tumor or a metastatic site within 4 years
  4. Previous radiation therapy of brain metastatic lesion(s)
  5. A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis
  6. 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:

1. Patients with a history of active hematological malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients
Single intravenous administration of 18F fluciclovine for PET Scan
Drug: 18F fluciclovine
18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus
Other Names:
  • Axumin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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.
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.
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.
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 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.
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 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.
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 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.
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 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.
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.
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.
Follow up through 6 months after PET scan.
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
Follow up through 6 months after PET scan.
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.
Follow up through 6 months after PET scan.
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.
PET Scan Day 1
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.
PET Scan Day 1
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.
The vital signs collected between 5 to 60 minutes before and after the PET scan.
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.
The vital signs collected between 5 to 60 minutes before and after the PET scan.
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.
The vital signs collected between 5 to 60 minutes before and after the PET scan.
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.
The vital signs collected between 5 to 60 minutes before and after the PET scan.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Blue Earth Diagnostics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Precision For Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BED-FLC-312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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