Actively Recruiting
A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy
Led by M.D. Anderson Cancer Center · Updated on 2026-04-15
20
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
B
Blue Earth Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain metastatic lesions in patients who are receiving immunotherapy.
CONDITIONS
Official Title
A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status 0 to 2 or Karnofsky score 60% or higher
- Willing and able to provide written informed consent
- Documented brain metastatic lesion(s) in medical records
- Currently receiving active immunotherapy for the diagnosed cancer
- At least one metastatic brain lesion showing suspected pseudoprogression on standard imaging (CT, MRI, or various PET-CT scans)
- Suspected pseudoprogression determined by imaging or treating physicians
- Able and willing to have follow-up Fluciclovine PET-CT within 60 days of standard imaging
- Able and willing to undergo biopsy if needed as part of standard care
- Estimated life expectancy of at least 3 months as judged by investigator or physician
You will not qualify if you...
- Pregnant or breastfeeding during study participation
- History of severe allergic reactions to Axumin radiopharmaceuticals
- Psychiatric illness or social situations limiting compliance with study requirements
- Unable to lie flat or tolerate PET-CT scan
- Contraindications to Axumin injection are unknown but none currently established
- Any medical condition or circumstance that may compromise safety, compliance, or reliable study data as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Y
Yang Lu, MD
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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