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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

Tracking Information
First Submitted Date  ICMJE May 27, 2020
First Posted Date  ICMJE June 1, 2020
Last Update Posted Date April 12, 2022
Actual Study Start Date  ICMJE October 26, 2020
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2020)
  • Specificity of 18F fluciclovine [ Time Frame: 6 months ]
    Use Negative Percent Agreement (NPA) to assess specificity of 18F fluciclovine PET in detecting recurrent brain metastases.
  • Sensitivity of 18F fluciclovine [ Time Frame: 6 months ]
    Use Positive Percent Agreement (PPA) to assess specificity of 18F fluciclovine PET in detecting recurrent brain metastases.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2020)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2020)
Number of participants with treatment-related adverse events as classified by MedDRA [ 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 throughout the study period.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Positron Emission Tomography (PET) Imaging study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Brain Metastases
Intervention  ICMJE Drug: 18F fluciclovine
18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus
Other Name: Axumin
Study Arms  ICMJE Experimental: Patients
Single intravenous administration of 18F fluciclovine for PET Scan
Intervention: Drug: 18F fluciclovine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04410133
Other Study ID Numbers  ICMJE BED-FLC-312
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Blue Earth Diagnostics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Blue Earth Diagnostics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Precision For Medicine
Investigators  ICMJE Not Provided
PRS Account Blue Earth Diagnostics
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP