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18F-fluciclovine for Brain Tumor (FACBC Trial)

Q: Are there still available slots for participants in this investigation?

Indeed, the latest information on clinicaltrials.gov demonstrates that this medical experiment is accepting participants. The trial was initially posted in October of 2019 and underwent its last edit in February 2022; at present it requires 10 patients across a single site.

Q: What is the estimated enrollment size of this experiment?

Affirmative, according to clinicaltrials.gov this scientific study is actively recruiting participants since its initial posting on October 22nd 2019 and last update taking place February 7th 2022. The research team needs a total of 10 patients for the single location currently involved in the trial.

Q: Are there other precedents for employing 18F-fluciclovine in clinical research?

Presently, the study of 18F-fluciclovine is largely in its developmental stages with 3 ongoing trials and none reaching Phase 3. Salt Lake City, <a href="https://www.withpower.com/clinical-trials/utah">Utah</a> serves as a primary site for these investigations but there are 2 additional locations that have launched relevant studies.

Q: Is this a pioneering clinical trial?

Research of 18F-fluciclovine began in 2018, when Blue Earth Diagnostics sponsored the first clinical trial with 30 participants. Subsequently, this medication received Phase 2 approval and currently 3 trials are underway across two cities and one nation.

Phase < 1

Waitlist Available

Led By James M Mountz, MD

Research Sponsored by James Mountz

Eligibility Criteria Checklist

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

Must have

1. Age ≥ 18 years old.

2. Been previously diagnosed by resection or biopsy with grade 3 or 4 glioma.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 minutes

Awards & highlights

FACBC Trial Summary

This trial is testing a new way to tell if cancer is growing back after treatment using a different kind of scan.

FACBC Trial Eligibility Criteria

Inclusion Criteria

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

FACBC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 minutes for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To assess the ability of [F-18]fluciclovine to differentiate radionecrosis (pseudoprogression) from tumor recurrence (progression) in patients after therapy, at imaging time points within the 12 week interval post chemoradiation.

FACBC Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with GliomaExperimental Treatment1 Intervention

[F18]fluciclovine will be utilized to assess tumor viability compared with F-18 FDG PET or diagnostic MRI.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-fluciclovine

2021

Completed Early Phase 1

~40

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

James MountzLead Sponsor

Blue Earth DiagnosticsIndustry Sponsor

38 Previous Clinical Trials

2,978 Total Patients Enrolled

James M Mountz, MDPrincipal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

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

Are there still available slots for participants in this investigation?

"Indeed, the latest information on clinicaltrials.gov demonstrates that this medical experiment is accepting participants. The trial was initially posted in October of 2019 and underwent its last edit in February 2022; at present it requires 10 patients across a single site."

Answered by AI

What is the estimated enrollment size of this experiment?

"Affirmative, according to clinicaltrials.gov this scientific study is actively recruiting participants since its initial posting on October 22nd 2019 and last update taking place February 7th 2022. The research team needs a total of 10 patients for the single location currently involved in the trial."

Answered by AI

Are there other precedents for employing 18F-fluciclovine in clinical research?

"Presently, the study of 18F-fluciclovine is largely in its developmental stages with 3 ongoing trials and none reaching Phase 3. Salt Lake City, Utah serves as a primary site for these investigations but there are 2 additional locations that have launched relevant studies."

Answered by AI

Is this a pioneering clinical trial?

"Research of 18F-fluciclovine began in 2018, when Blue Earth Diagnostics sponsored the first clinical trial with 30 participants. Subsequently, this medication received Phase 2 approval and currently 3 trials are underway across two cities and one nation."

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

Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma

James Mountz 2019. "Evaluation of 18F-fluciclovine (FACBC) PET/MR Uptake in Participants With Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04114370.