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Axumin PET-CT for Brain Cancer

N/A

Recruiting

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.

Must not have

Pregnant or breastfeeding during participation in the study due to potential risk of adverse developmental outcomes and fetal harm from Fluciclovine F18.

Unable to lie flat during or tolerate PET-CT.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I cannot lie flat for scans due to discomfort or other reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met