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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

FACILITATE Trial 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.Check my eligibility

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.See study design

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.

FACILITATE Trial 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).

FACILITATE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in SUVmax

Change in SUVmean

Change in Standardized Uptake Value (SUV)-peak

Secondary outcome measures

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

FACILITATE 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Blue Earth DiagnosticsIndustry Sponsor

38 Previous Clinical Trials

2,941 Total Patients Enrolled

Baptist Health South FloridaLead Sponsor

48 Previous Clinical Trials

7,785 Total Patients Enrolled

Rupesh Kotecha, M.D.Principal InvestigatorMiami Cancer Institute at Baptist Health, Inc.

1 Previous Clinical Trials

46 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for new participants to join this research endeavor?

"According to information available on clinicaltrials.gov, this trial is not actively seeking participants at the present time- it was first posted November 1st 2023 and last edited September 15th 2023. However, there are 949 other ongoing studies that may be recruiting patients right now."

Answered by AI

Has the FDA ratified 18F-Fluciclovine PET Imaging?

"Pending more clinical research, the safety of 18F-Fluciclovine PET Imaging has been assigned a score 1. This is due to its current status as a Phase 1 trial - limited data available on efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

2024. "18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06048094.