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18F-Fluciclovine Imaging for Brain Tumors (CONCORDANT Trial)
Phase 2
Recruiting
Led By Rupesh R 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
CONCORDANT Trial Summary
This trial is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS). It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether the imaging agent, 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease.
Who is the study for?
This trial is for adults over 18 who've had brain surgery to remove metastasis and are set for follow-up radiosurgery. They must be in a stable enough condition (ECOG 0-3) and agree to use two effective contraception methods if of reproductive potential. It's not for those with prior whole-brain radiation, MRI contraindications, pregnancy during the study period, breastfeeding without pausing it post-imaging, previous severe reaction to 18F-Fluciclovine or leptomeningeal disease.Check my eligibility
What is being tested?
The trial tests an imaging agent called 18F-Fluciclovine in patients after brain metastasis surgery but before stereotactic radiosurgery. The aim is to see if this agent can better reveal remaining tumor tissue compared to standard MRI and help detect recurrence more effectively.See study design
What are the potential side effects?
Potential side effects from the investigational imaging agent include allergic reactions like anaphylaxis based on exclusion criteria; however, specific side effects are not detailed here.
CONCORDANT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Positron-Emission Tomography
Change in conformality index of tumor target volume delineation
Secondary outcome measures
Time to local failure
Side effects data
From 2020 Phase 2 trial • 21 Patients • NCT032637808%
Sepsis
8%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
18F-Fluciclovine
CONCORDANT Trial Design
1Treatment groups
Experimental Treatment
Group I: PET/CT, MRIExperimental Treatment1 Intervention
All patients will obtain an 18F-Fluciclovine PET/CT scan in addition to the planning MRI at the time of SRS treatment (approximately 2-4 weeks after resection). The value of 18F-Fluciclovine in addition to structural information from the MRI will be analyzed. Patients will continue to undergo 18F-Fluciclovine in addition to MRI during routine follow-up to determine the ability of 18F-Fluciclovine PET/CT to identify areas at risk for marginal failure, monitor resection beds for tumor control, identify patients at risk for disease recurrence, and detect patterns of failure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-Fluciclovine
2017
Completed Phase 2
~30
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, M.D.Principal InvestigatorMiami Cancer Institute/Baptist Health South Florida
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to the lining of my brain and spinal cord.I have been diagnosed with brain metastasis through imaging tests.I am scheduled for radiation therapy after surgery.I have had whole-brain radiation therapy before.I cannot have an MRI due to safety reasons like having a pacemaker.I plan to breastfeed during the trial and can stop for 24 hours after imaging.I can care for myself but may not be able to do heavy physical work.I am scheduled for surgery to remove at least one cancer spread.I am 18 years old or older.I am using two effective birth control methods if of childbearing potential.
Research Study Groups:
This trial has the following groups:- Group 1: PET/CT, MRI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are PET/CT and MRI scans safe procedures for patients to undergo?
"Due to the Phase 2 clinical trial status, there is moderate assurance of safety but no efficacy evidence yet for PET/CT and MRI. Therefore, it has been given a score of 2 on our risk assessment scale."
Answered by AI
Are there currently any opportunities to enroll in the clinical trial?
"According to data hosted on clinicialtrials.gov, the trial in question is not actively recruiting patients at this time - with its initial posting being December 1st 2022 and most recent update occurring November 8th 2022. Nonetheless, there are still 889 other clinical trials that remain open for enrollment presently."
Answered by AI
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