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Trial record 1 of 1 for:    04410367
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Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE) (PURSUE)

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: NCT04410367
Recruitment Status : Completed
First Posted : June 1, 2020
Last Update Posted : January 6, 2022
Sponsor:
Collaborator:
Precision For Medicine
Information provided by (Responsible Party):
Blue Earth Diagnostics

Brief Summary:
An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 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 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 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 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy
Actual Study Start Date : August 31, 2020
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Sensitivity of different thresholds of lesion 18F fluciclovine uptake on visual reads . [ Time Frame: 60 days ]
    Sensitivity of different thresholds of lesion 18F fluciclovine uptake on visual reads compared to central histopathological analysis.

  2. Specificity of different thresholds of lesion 18F fluciclovine uptake on visual reads. [ Time Frame: 60 days ]
    Specificity of different thresholds of lesion 18F fluciclovine uptake on visual reads compared to central histopathological analysis.


Secondary Outcome Measures :
  1. Sensitivity of different thresholds of quantitative and dynamic measures of lesion 18F fluciclovine uptake. [ Time Frame: 60 days ]
    Sensitivity of different thresholds of quantitative and dynamic measures of lesion 18F fluciclovine uptake compared to central histopathological analysis.

  2. Specificity of different thresholds of quantitative and dynamic measures of lesion 18F fluciclovine uptake. [ Time Frame: 60 days ]
    Specificity of different thresholds of quantitative and dynamic measures of lesion 18F fluciclovine uptake compared to central histopathological analysis.

  3. Treatment-emergent adverse events [ Time Frame: 2 days post-18F-fluciclovine administration ]
    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.



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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 0-2
  2. Previous history of solid tumor brain metastasis of any origin
  3. Histopathological confirmation of the primary solid tumor or a metastatic site
  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 craniotomy

Exclusion Criteria:

1. Patients with a history of active hematological malignancy


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): NCT04410367


Locations
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United States, California
John Wayne Cancer Institute at Providence St. John's Health Center
Santa Monica, California, United States, 90404
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06519
United States, Florida
Miami Cancer Institute
Miami, Florida, United States, 33176
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70131
United States, Missouri
Washington University School of Medicine Center for Clinical Imaging Research
Saint Louis, Missouri, United States, 63110
United States, New York
NYU Langone Health
New York, New York, United States, 10016
United States, Ohio
University Hospital Cleveland
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
Center for Quantitative Cancer Imaging at Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Blue Earth Diagnostics
Precision For Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Blue Earth Diagnostics
ClinicalTrials.gov Identifier: NCT04410367    
Other Study ID Numbers: BED-FLC-219
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: January 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