PET/CT, MRI for Brain Tumors

Phase-Based Progress Estimates
Miami Cancer Institute at Baptist Health South Florida, Miami, FLBrain Tumors+1 More18F-Fluciclovine - Drug
All Sexes
What conditions do you have?

Study 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.

Eligible Conditions
  • Metastatic Brain Tumors
  • Cancer Brain Metastases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 1 year

1 year
Time to local failure
Month 12
Positron-Emission Tomography
Change in conformality index of tumor target volume delineation

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

8%Urinary tract infection
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03263780) in the 18F-Fluciclovine ARM group. Side effects include: Sepsis with 8%, Urinary tract infection with 8%.

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: PET/CT, MRI · No Placebo Group · Phase 2

Experimental Group · 1 Intervention: 18F-Fluciclovine · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Blue Earth DiagnosticsIndustry Sponsor
28 Previous Clinical Trials
2,591 Total Patients Enrolled
Baptist Health South FloridaLead Sponsor
45 Previous Clinical Trials
7,863 Total Patients Enrolled
Rupesh R Kotecha, M.D.Principal InvestigatorMiami Cancer Institute/Baptist Health South Florida

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are scheduled to have surgery to remove at least one metastasis.
You are scheduled to have a procedure called postoperative SRS (stereotactic radiosurgery).

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

Are there currently any opportunities to enroll in the clinical trial?

"According to data hosted on, 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.