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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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.

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

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

Primary outcome measures

Change in sensitivity for MRI

PET/CT scan

Change in the standardized uptake value (SUV) parameters

Secondary outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baptist Health South FloridaLead Sponsor

48 Previous Clinical Trials

7,811 Total Patients Enrolled

Blue Earth DiagnosticsIndustry Sponsor

38 Previous Clinical Trials

2,967 Total Patients Enrolled

Rupesh R Kotecha, MDPrincipal InvestigatorMiami Cancer Institute (MCI) at Baptist Health, Inc.

2 Previous Clinical Trials

274 Total Patients Enrolled

Media Library

PET/CT, MRI Clinical Trial Eligibility Overview. Trial Name: NCT04689048 — Phase 1

Brain Metastases Research Study Groups: PET/CT, MRI

Brain Metastases Clinical Trial 2023: PET/CT, MRI Highlights & Side Effects. Trial Name: NCT04689048 — Phase 1

PET/CT, MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04689048 — Phase 1

Frequently Asked Questions

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

How many participants are currently enrolled in this research trial?

"Affirmative. Clinicaltrials.gov houses the information that indicates this trial is actively seeking participants, which commenced on April 4th 2022 and was last updated November 18th 2022. The medical research requires 20 patients from two distinct sites to be recruited for inclusion in the study."

Answered by AI

Does the medical literature document any precedent for this therapy?

"Presently, there are 7 active clinical trials researching this treatment, with one of the studies in its final phase. Most of these medical experiments are taking place close to Boston; however 28 different medical centres have launched similar investigations."

Answered by AI

Has there ever been a similar investigation of this kind?

"Currently, seven clinical trials are underway in 21 cities across a single nation. The initial study of this treatment was launched by Telix International Pty Ltd back in 2019 and concluded its second phase drug approval stage with 140 participants involved. In the two years that have followed, five more studies have been successfully completed."

Answered by AI

Is there still room for enrolment in this clinical experiment?

"Affirmative. Clinicaltrials.gov records show that, as of November 18th 2022, this clinical trial is still recruiting participants for its study. Initially posted on April 4th 2022, the research requires 20 patients from 2 different sites."

Answered by AI

What adverse effects could patients potentially experience with this treatment?

"As this is an early-phase trial, the safety of this drug has been assessed as a 1. This reflects that there is only minimal clinical data to suggest efficacy and limited evidence on its overall security."

Answered by AI

Recent research and studies

Neuro-OncologyJournal

Letter Regarding “contribution of PET Imaging to Radiotherapy Planning and Monitoring in Glioma Patients—a Report of the PET/RANO Group

Kotecha, Rupesh, Mariam Aboian, Seyed Ali Nabavizadeh, Ephraim E Parent, Daniel M Trifiletti, and Samuel T Chao. 2021. “Letter Regarding “contribution of PET Imaging to Radiotherapy Planning and Monitoring in Glioma Patients—a Report of the PET/RANO Group”: 18f-fluciclovine and Target Volume Delineation”. Neuro-oncology. Oxford University Press (OUP). doi:10.1093/neuonc/noab097.

clinicaltrials.govStudy

Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery

2022. "Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04689048.

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