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18F-Fluciclovine PET Imaging for Brain Tumor Recurrence (DRARCH Trial)
Phase 3
Recruiting
Led By Poonam Choudhary, PhD
Research Sponsored by Nicole Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights
DRARCH Trial Summary
This trial will test if PET imaging can detect cancer spread earlier than MRI, helping to better tailor treatments.
Who is the study for?
This trial is for adults over 18 with a high-grade glioma brain tumor (WHO grade III or IV) who have finished or are undergoing standard therapy. They must not be pregnant, agree to use birth control, and be able to give consent. People can't join if they're claustrophobic, have certain medical devices, kidney issues, allergies to MRI/ PET scan materials, or are in another interfering trial.Check my eligibility
What is being tested?
The study tests whether PET scans using a tracer called fluciclovine can more accurately detect if a brain tumor has come back after treatment compared to traditional MRI scans. It aims to identify true tumor recurrence earlier.See study design
What are the potential side effects?
Potential side effects from the fluciclovine PET imaging may include allergic reactions to the tracer and discomfort due to lying still during the scan. The procedure involves exposure to a small amount of radiation.
DRARCH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain tumor progression
Secondary outcome measures
PET uptake and dynamic susceptibility contrast (DSC) perfusion
DRARCH Trial Design
1Treatment groups
Experimental Treatment
Group I: PET studyExperimental Treatment1 Intervention
Single intravenous administration of 18F fluciclovine for PET Scan
Find a Location
Who is running the clinical trial?
Blue Earth DiagnosticsIndustry Sponsor
38 Previous Clinical Trials
2,957 Total Patients Enrolled
Nicole HillLead Sponsor
1 Previous Clinical Trials
140 Total Patients Enrolled
Barrow Neurological FoundationOTHER
7 Previous Clinical Trials
21,557 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: PET study
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the FDA's current stance on PET study?
"There is some efficacy data from Phase 3 trials to support the safety of PET scans, so our team gives it a score of 3."
Answered by AI
Are people with the required qualifications able to sign up for this clinical trial right now?
"The trial is presently looking for patients, as seen on clinicaltrials.gov. This study was originally posted on 8/24/2022, with the latest update being on 10/25/2022."
Answered by AI
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