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

Primary Purpose

Brain Metastases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
18F fluciclovine
Sponsored by
Blue Earth Diagnostics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Metastases focused on measuring Recurrent Brain Metastases, Diagnostic, Positron Emission Tomography (PET) Scan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • St. Joseph's Hospital and Medical Center
  • University of California, San Francisco
  • John Wayne Cancer Institute at Providence St. John's Health Center
  • Yale School of Medicine
  • Miami Cancer Institute at Baptist Health, Inc.
  • Medical College of Georgia, Augusta University
  • Ochsner Clinic Foundation
  • Johns Hopkins Hospital
  • University of Michigan Rogel Cancer Center
  • Henry Ford Hospital
  • Washington University School of Medicine-Center for Clinical Imaging Research
  • NYU Langone Health
  • University Hospital Cleveland
  • Cleveland Clinic
  • University of Pennsylvania Health System
  • The University of Texas MD Anderson Cancer Center
  • Center for Quantitative Cancer Imaging at Huntsman Cancer Institute
  • West Virgina University Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

Single intravenous administration of 18F fluciclovine for PET Scan

Outcomes

Primary Outcome Measures

Positive Percent Agreement (PPA) of 18F-fluciclovine PET in detecting recurrent brain metastases
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
NPA (equivalent to specificity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.

Secondary Outcome Measures

Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases
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
Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
Treatment-emergent adverse events
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.

Full Information

First Posted
May 27, 2020
Last Updated
July 11, 2023
Sponsor
Blue Earth Diagnostics
Collaborators
Precision For Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04410133
Brief Title
Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases
Acronym
REVELATE
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
June 5, 2023 (Actual)
Study Completion Date
June 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blue Earth Diagnostics
Collaborators
Precision For Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
Recurrent Brain Metastases, Diagnostic, Positron Emission Tomography (PET) Scan

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Positron Emission Tomography (PET) Imaging study
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Single intravenous administration of 18F fluciclovine for PET Scan
Intervention Type
Drug
Intervention Name(s)
18F fluciclovine
Other Intervention Name(s)
Axumin
Intervention Description
18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus
Primary Outcome Measure Information:
Title
Positive Percent Agreement (PPA) of 18F-fluciclovine PET in detecting recurrent brain metastases
Description
PPA (equivalent to sensitivity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
Time Frame
6 months
Title
Negative Percent Agreement (NPA) of 18F-fluciclovine PET in detecting recurrent brain metastases
Description
NPA (equivalent to specificity) of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases
Description
Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
Time Frame
6 months
Title
Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases
Description
Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases on a subject-level.
Time Frame
6 months
Title
Treatment-emergent adverse events
Description
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.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 1. Patients with a history of active hematological malignancy
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
John Wayne Cancer Institute at Providence St. John's Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Miami Cancer Institute at Baptist Health, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Medical College of Georgia, Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70131
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University School of Medicine-Center for Clinical Imaging Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University Hospital Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Center for Quantitative Cancer Imaging at Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
West Virgina University Cancer Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34081125
Citation
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.
Results Reference
derived

Learn more about this trial

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

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