Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Javier Villanueva-Meyer
Headshot of Javier Villanueva-Meyer
Javier Villanueva-Meyer

Description

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

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

Keywords

Brain Metastases Recurrent Brain Metastases Diagnostic Positron Emission Tomography (PET) Scan Neoplasm Metastasis Neoplasms, Second Primary Brain Neoplasms 18F fluciclovine

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  1. Patients with a history of active hematological malignancy

Locations

  • University of California, San Francisco
    San Francisco California 94118 United States
  • John Wayne Cancer Institute at Providence St. John's Health Center
    Santa Monica California 90404 United States

Lead Scientist at UCSF

  • Javier Villanueva-Meyer
    Javier Villanueva­-Meyer, MD, is an Assistant Professor of Clinical Radiology in the Neuroradiology subspecialty section in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Blue Earth Diagnostics
ID
NCT04410133
Phase
Phase 3 Brain Metastases Research Study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated