Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID04689048

Characterization of Large Brain Metastases Using 18F-Fluciclovine PET/CT with Staged Stereotactic Radiosurgery

Led by Baptist Health South Florida · Updated on 2026-04-22

20

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

Sponsors

B

Baptist Health South Florida

Lead Sponsor

B

Blue Earth Diagnostics

Collaborating Sponsor

AI-Summary

What this Trial Is About

Brain metastases occur when cancer spreads to the brain and are a common complication in cancer patients. Researchers are studying a new imaging agent called 18F-fluciclovine to see if it can detect which patients respond to radiation therapy. The study also aims to monitor changes in the treated brain metastases over time using this imaging agent. Participants will receive three 18F-fluciclovine PET/CT brain scans: before treatment, during treatment, and after treatment. The 18F-fluciclovine, also known as Axumin, is given as an intravenous injection with a maximum undiluted volume of 5 mL, followed by a saline flush. Patients must fast for at least four hours before injection, and PET images will be collected and analyzed to assess treatment response. During the study, participants will undergo PET/CT and MRI scans at multiple time points up to one year to evaluate changes in imaging sensitivity and standardized uptake value (SUV) parameters. Researchers will compare PET and MRI results over time to understand the effects of radiation therapy on brain metastases. Patient safety and treatment response will be closely monitored throughout the study period.

CONDITIONS

Brief Title

Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, age 18 years or older
  • Eastern Cooperative Oncology Group performance status of 0 to 2
  • Confirmed diagnosis of brain metastases with at least one untreated lesion larger than 2 cm
  • Planned treatment with staged stereotactic radiosurgery (SSRS)
  • Negative serum pregnancy test within 14 days for women of childbearing potential
  • Use of highly effective contraception for at least 4 weeks prior and during study participation for females of reproductive potential
Not Eligible

You will not qualify if you...

  • Previous anaphylactic reaction to 18F-fluciclovine
  • Evidence of leptomeningeal disease
  • Prior whole-brain radiation therapy
  • Contraindications to MRI, such as having a pacemaker
  • Pregnant women at the time of 18F-fluciclovine administration
  • Breastfeeding women unwilling to stop for 24 hours after imaging
  • Major medical illness or psychiatric/cognitive impairments that prevent study completion or informed consent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Approximately 1 year

Participants receive three 18F-fluciclovine PET/CT brain scans before, during, and after staged stereotactic radiosurgery treatment. The scans involve intravenous injection of 18F-fluciclovine and brain imaging to assess brain metastases.

3 PET/CT brain scan visits (pre-treatment, interim, post-treatment)

Trial Site Locations

Total: 1 location

1

Miami Cancer Institute

Miami, Florida, United States, 33176

Actively Recruiting

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Research Team

R

Rupesh C Kotecha, MD

K

Kristy Reyes

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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Published Research Related To This Trial

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.

Rupesh Kotecha, Mariam Aboian, Seyed Ali Nabavizadeh...

https://pubmed.ncbi.nlm.nih.gov/34081125