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Axumin PET-CT for Brain Cancer
N/A
Waitlist Available
Led By Yang Lu, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status ≤2 (Karnofsky ≥60%).
Age ≥18 years. Patients <18 years of age are excluded from this study due to lack of dosing or adverse event data on the use of Axumin in pediatric patients.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial tests if a PET-CT scan can detect brain tumors better in people who get immunotherapy.
Who is the study for?
Adults over 18 with brain metastases from cancer, currently on immunotherapy, can join this trial. They must be able to consent, have a life expectancy of at least 3 months, and be willing to undergo additional scans or biopsies if needed. Pregnant or breastfeeding individuals, those with severe allergies to Axumin PET radiopharmaceuticals, or conditions affecting study compliance are excluded.Check my eligibility
What is being tested?
The trial is testing whether a special type of PET-CT scan using a tracer called 18F-Fluciclovine (Axumin) is more effective in distinguishing between true progression and pseudo-progression of brain tumors in patients undergoing immunotherapy.See study design
What are the potential side effects?
While the side effects for Fluciclovine F18 aren't fully known yet, potential risks include allergic reactions. The procedure involves lying flat during the PET-CT scan which some may find uncomfortable.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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I have a brain tumor that might be falsely showing signs of getting worse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: 18F-Fluciclovine (Axumin)Experimental Treatment2 Interventions
Participants are expected to be in this research study for about 6-12 months. Participants will have up to 6 visits for screening tests, Axumin PET-CT scans, and information collection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pet Scan
2011
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,301 Total Patients Enrolled
Blue Earth DiagnosticsIndustry Sponsor
38 Previous Clinical Trials
2,967 Total Patients Enrolled
Yang Lu, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
120 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment currently enrolling participants?
"According to the information provided on clinicaltrials.gov, this particular medical trial is not currently looking for participants as it has already been updated on August 23rd, 2023. Nonetheless, there are an additional 924 trials actively seeking patients at present time."
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