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18F-Fluciclovine PET for Brain Cancer (FACILITATE Trial)

Phase 1

Recruiting

Led By Rupesh Kotecha, M.D.

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

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Diagnosis of cancer with radiographic finding of brain metastasis

Must not have

Prior whole-brain radiation therapy

Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at using PET scans to measure response to brain cancer treatment with stereotactic radiosurgery.

Who is the study for?

This trial is for cancer patients with small brain metastases (≤2cm) who are set to receive stereotactic radiosurgery. They must be in fair health (ECOG 0-2), not pregnant, and agree to use two effective contraception methods. It's not for those allergic to 18F-fluciclovine, unable to have an MRI, breastfeeding without a pause post-imaging, or with major illnesses that affect study participation.

What is being tested?

The study tests if the imaging agent 18F-Fluciclovine PET can track how well brain metastases respond after being treated with stereotactic radiosurgery—a precise radiation therapy aimed at tumors in the brain.

What are the potential side effects?

While specific side effects of 18F-Fluciclovine PET aren't detailed here, common ones from similar agents include injection site discomfort, nausea, or a rare chance of allergic reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to get out of my bed or chair and move around.

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My cancer has spread to my brain, confirmed by imaging.

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All my brain tumors are 2 cm or smaller.

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My doctor has planned for me to receive stereotactic radiosurgery (SRS).

Exclusion Criteria

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

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I have had whole-brain radiation therapy before.

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I cannot have an MRI due to safety reasons like having a pacemaker.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months 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 SUVmax

Change in SUVmean

Change in Standardized Uptake Value (SUV)-peak

Secondary study objectives

Tumor Control

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: 18F-Fluciclovine PET ImagingExperimental Treatment1 Intervention

Participants will undergo a 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). Then participants will undergo single-fraction SRS as standard of care (SOC). A second 18F-fluciclovine PET scan will be completed 8 weeks (± 2 weeks) after SRS.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F fluciclovine

2020

Completed Phase 3

~180

0 / 6Eligibility criteria met