Actively Recruiting

Phase 2
Age: 18Years - 99Years
All Genders
NCT06055790

Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis

Led by University of Arizona · Updated on 2025-09-03

20

Participants Needed

1

Research Sites

111 weeks

Total Duration

On this page

Sponsors

U

University of Arizona

Lead Sponsor

B

Blue Earth Diagnostics

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this diagnostic intervention clinical trial is to compare 18F-Fluciclovine uptake within brain lesions over 60 minutes compared with standard of care positive histology confirmation or confirmation MRI images. The main questions it aims to answer are: 1. What are the dynamics of 18F-Fluciclovine update within a non-treated metastatic brain lesion over 60 minutes? 2. What are the dynamics of 18F-fluciclovine update within recently treated metastatic brain lesions? 3. What is the potential use of 18F-Fluciclovine in delineating true local progression from radionecrosis in patients with clinical uncertainty of indeterminate MRI? Participants will undergo an 18F-fluciclovine head PET/CT scan prior to treatment for brain metastatic lesion(s). The study will characterize uptake dynamic PET images over 60 minutes. Uptake within the lesions and the benign brain parenchyma will be plotted on a time activity curve for 60 mins. Patients will undergo a second 18F-fluciclovine PET/CT to evaluate 18F-fluciclovine uptake in treated lesions over 60 minutes. This will be offered concurrently with the post-procedure standard of care (SOC) MRI to evaluate post-treatment changes. Uptake within the lesions and the benign brain parenchyma will be plotted on a 60 min time activity curve. Results will be compared to the pre-treatment baseline images. A third 18F-fluciclovine PET/CT will be offered to evaluate post radiation changes necrosis from recurrence, for up to 10 patients in our cohort who are under clinical surveillance (up to three years surveillance) and developed MRI evidence of either true progression or radionecrosis with clinical uncertainty after stereotactic radiosurgery. The initial 18F-fluciclovine PET/CT will serve as a baseline PET/CT scan. This will be compared to post procedural histological confirmation.

CONDITIONS

Official Title

Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with clinically suspected or diagnosed brain metastatic lesion(s)
  • Age 18 years or older
  • Known history of cancer
  • Brain MRI within past 2 months positive for metastatic disease
  • Scheduled for treatment with surgical resection, stereotactic radiosurgery, or whole brain radiation therapy
  • Able to tolerate 18F-fluciclovine PET/CT exam (can lie still on their back for the scan duration)
  • Ability to understand and willingness to sign written informed consent
Not Eligible

You will not qualify if you...

  • Patients not meeting inclusion criteria
  • Brain biopsy of index lesion(s) performed less than 4 weeks before 18F-fluciclovine PET/CT
  • Prior brain surgery or radiation treatment of the index lesion(s)
  • Treatment of the index brain lesion(s) or start of systemic therapy after last MRI and before PET/CT scan
  • Only index lesions located within prior radiation treatment field (10% isodose line) without any lesion outside this area
  • Inability to tolerate 18F-fluciclovine PET/CT exam
  • Enrollment that delays patient care
  • Concurrent or prior enrollment in other clinical trials allowed if all other criteria are met

AI-Screening

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Trial Site Locations

Total: 1 location

1

Arizona Cancer Center at UMC North/University Medical Center

Tucson, Arizona, United States, 85719

Actively Recruiting

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Research Team

R

Rachel E Jarrett, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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