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18F-Fluciclovine Imaging for Brain Metastases

Phase 1

Recruiting

Led By Rupesh R Kotecha, MD

Research Sponsored by Baptist Health South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Performance status, Eastern Cooperative Oncology Group 0-2

Confirmed diagnosis of brain metastases with at least one untreated lesion >2 cm in maximum diameter

Must not have

Evidence of leptomeningeal disease

Prior whole-brain radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new imaging agent to see if it can detect which patients are responding to brain cancer radiation therapy, and to track changes in the brain metastases over time.

Who is the study for?

Adults over 18 with brain metastases and at least one untreated lesion larger than 2 cm can join this trial. They must have a performance status of 0-2, not be pregnant or breastfeeding (or willing to stop for the study), and agree to use effective contraception. Those with MRI contraindications, prior whole-brain radiation, or severe medical/psychiatric issues cannot participate.

What is being tested?

The trial is testing if a new imaging agent called 18F-fluciclovine can show how well patients with large brain metastases respond to staged stereotactic radiosurgery (SSRS). It will also monitor changes in the treated lesions using this agent over time.

What are the potential side effects?

Potential side effects include allergic reactions to the imaging agent. Since it involves radiation exposure from positron emission tomography/computerized tomography scans, there's a slight risk of long-term radiation effects.

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 and perform daily activities.

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I have a brain tumor larger than 2 cm that hasn't been treated.

Exclusion Criteria

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

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My cancer has spread to the lining of my brain and spinal cord.

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I have had whole-brain radiation therapy before.

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I am not pregnant at the time I will receive 18F-fluciclovine.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in sensitivity for MRI

PET/CT scan

Change in the standardized uptake value (SUV) parameters

Secondary study objectives

Compare change of SUV metrics of 18F-fluciclovine PET

Compare change of SUV metrics of contrast-enhanced MRI

Side effects data

From 2021 Phase 2 trial • 23 Patients • NCT04410367

Headache

100%

80%

60%

40%

20%

Study treatment Arm

18F-Fluciclovine Injection

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: PET/CT, MRIExperimental Treatment1 Intervention

In total, three 18F-fluciclovine PET/CT brain scans (pre-, interim-, and post-treatment) will be performed according to the study calendar. Generic name is Axumin and will be administered as an intravenous bolus. May administer diluted or undiluted. The maximum volume of undiluted 18F-fluciclovine is 5 mL. After administration, flush with normal saline to ensure full delivery of the dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F fluciclovine

2020

Completed Phase 3

~180

0 / 5Eligibility criteria met