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18F fluciclovine for Brain Tumor (REVELATE Trial)

Phase 3
Waitlist Available
Research Sponsored by Blue Earth Diagnostics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

REVELATE Trial Summary

This trial is testing how well a new imaging technique can detect cancer that has come back in the brain after radiation therapy.

Eligible Conditions
  • Metastatic Brain Tumors

REVELATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The doctor cannot determine if a certain brain lesion is a recurrent metastasis.

REVELATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Negative Percent Agreement (NPA) of 18F-fluciclovine PET in detecting recurrent brain metastases
Positive Percent Agreement (PPA) of 18F-fluciclovine PET in detecting recurrent brain metastases
Secondary outcome measures
Negative predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases
Positive predictive value of 18F-fluciclovine PET in detecting recurrent brain metastases
Therapeutic procedure

Side effects data

From 2021 Phase 2 trial • 23 Patients • NCT04410367
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
18F-Fluciclovine Injection

REVELATE Trial Design

1Treatment groups
Experimental Treatment
Group I: PatientsExperimental Treatment1 Intervention
Single intravenous administration of 18F fluciclovine for PET Scan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F fluciclovine
2020
Completed Phase 3
~180

Find a Location

Who is running the clinical trial?

Precision For MedicineIndustry Sponsor
4 Previous Clinical Trials
326 Total Patients Enrolled
Blue Earth DiagnosticsLead Sponsor
38 Previous Clinical Trials
2,866 Total Patients Enrolled

Frequently Asked Questions

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

What sort of health risks does 18F fluciclovine pose?

"Fluciclovine's safety is supported by prior Phase 3 trial data, so it received a score of 3."

Answered by AI

Are new patients being accepted into this clinical trial right now?

"The clinical trial mentioned is no longer recruiting patients, as the last update on the website was from 422 days ago. However, there are 952 other trials that are actively recruiting patients."

Answered by AI

Do we have any previous data to go on for this kind of treatment?

"7 clinical trials for 18F fluciclovine are currently underway in 21 cities and 1 country. The first study was completed in 2019 and it reached Phase 2 of drug approval. That initial study had 140 participants and was sponsored by Telix International Pty Ltd. In the 2 years since 2019, 5 more trials have been completed."

Answered by AI

Does 18F fluciclovine have a long history of research?

"The year 2019 saw the first study of 18F fluciclovine at Emory Saint Joseph's Hospital. As of now, there have been 5 completed clinical trials. Additionally, there are 7 clinical trials underway, many of which are based in Houston, Texas."

Answered by AI

How many people are allowed to sign up for this experiment?

"Unfortunately, this particular clinical trial is no longer recruiting patients. Originally posted on October 26th 2020, this study was last updated on April 11th, 2022. However, there are still many other trials looking for participants. There are 945 clinical trials actively seeking patients with neoplasm metastasis and 7 trials for 18F fluciclovine that are still looking for candidates."

Answered by AI

In how many different settings is this research being conducted?

"To minimize participant burden, the trial's 19 sites are located in major cities including Houston, Salt Lake City, and Cleveland. Travel should not be a significant issue for prospective participants."

Answered by AI
~34 spots leftby Mar 2025