Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05554302

Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Patients with Resected Brain Metastases Undergoing Postoperative Stereotactic Radiosurgery

Led by Baptist Health South Florida · Updated on 2025-12-01

20

Participants Needed

1

Research Sites

N/A

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

Researchers are studying patients who have undergone surgery to remove brain metastases and are scheduled for stereotactic radiosurgery (SRS) afterward. The study aims to evaluate whether the imaging agent 18F-Fluciclovine, used alongside MRI, can better detect residual tumor tissue and identify recurrent disease that MRI alone might miss. This agent is investigational for imaging brain metastases. Participants will receive a 5-mCi dose of 18F-Fluciclovine through an intravenous injection after fasting for at least four hours. The PET/CT scan using this agent will be performed at the time of SRS treatment, about 2 to 4 weeks after surgery, alongside the standard MRI. Patients will continue to have combined 18F-Fluciclovine PET/CT and MRI scans during routine follow-ups to monitor tumor control, detect recurrence, and assess areas at risk. During the study, participants will undergo PET/CT imaging sessions with 18F-Fluciclovine and MRI scans at baseline and at 3 weeks, 6 months, and 12 months. Researchers will measure changes in tumor volume delineation and PET scan uptake values to assess treatment response. Safety and tumor control will also be monitored, with follow-up assessments extending to at least one year. The total study duration varies by participant based on follow-up timing.

CONDITIONS

Brief Title

Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 3
  • Radiographic diagnosis of brain metastasis
  • Planned surgical removal of at least one brain metastasis
  • Planned postoperative stereotactic radiosurgery (SRS)
  • Male or female patients of reproductive potential must use two effective contraception methods for at least 4 weeks before screening and during study participation plus 1 week after post-treatment imaging
  • Postmenopausal participants defined by specific clinical or hormonal criteria or surgical sterilization
Not Eligible

You will not qualify if you...

  • Prior anaphylactic reaction to 18F-Fluciclovine
  • Evidence of leptomeningeal disease
  • Prior whole-brain radiation therapy
  • Contraindication to MRI, such as presence of a pacemaker
  • Pregnancy at the expected time of 18F-Fluciclovine administration
  • Breastfeeding at the time of imaging without willingness to stop breastfeeding for 24 hours after imaging

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants receive an 18F-Fluciclovine PET/CT scan in addition to the planning MRI at the time of stereotactic radiosurgery (SRS) treatment approximately 2 to 4 weeks after brain metastasis resection.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 12 months

Participants continue to undergo 18F-Fluciclovine PET/CT and MRI during routine follow-up to monitor tumor control, identify areas at risk for failure, and detect disease recurrence.

3 visits over 12 months (in-person)

Trial Site Locations

Total: 1 location

1

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, United States, 33176

Actively Recruiting

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Research Team

R

Rupesh R Kotecha, M.D.

A

Antoinette Pimentel

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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