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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04410133
Recruitment Status : Active, not recruiting
First Posted : June 1, 2020
Last Update Posted : April 12, 2022
Sponsor:
Collaborator:
Precision For Medicine
Information provided by (Responsible Party):
Blue Earth Diagnostics

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Brain Metastases Drug: 18F fluciclovine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Positron Emission Tomography (PET) Imaging study
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 Name: Axumin


Outcome Measures
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Primary Outcome Measures :
  1. Positive Percent Agreement (PPA) of 18F-fluciclovine PET in detecting recurrent brain metastases [ Time Frame: 6 months ]
    PPA (equivalent to sensitivity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.

  2. Negative Percent Agreement (NPA) of 18F-fluciclovine PET in detecting recurrent brain metastases [ Time Frame: 6 months ]
    NPA (equivalent to specificity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.


Secondary Outcome Measures :
  1. Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases [ Time Frame: 6 months ]
    Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.

  2. Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases [ Time Frame: 6 months ]
    Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.

  3. Treatment-emergent adverse events [ Time Frame: 48 hours ]
    Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F fluciclovine until 2 days post-18F-fluciclovine administration.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410133


Locations
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Sponsors and Collaborators
Blue Earth Diagnostics
Precision For Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Blue Earth Diagnostics
ClinicalTrials.gov Identifier: NCT04410133    
Other Study ID Numbers: BED-FLC-312
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Blue Earth Diagnostics:
Recurrent Brain Metastases
Diagnostic
Positron Emission Tomography (PET) Scan
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
 Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases