Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06048094

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

Led by Baptist Health South Florida · Updated on 2025-05-18

46

Participants Needed

1

Research Sites

159 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

This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.

CONDITIONS

Official Title

18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of cancer with radiographic finding of brain metastasis
  • Any number of brain metastasis, with all lesions 64 2 cm in maximum dimension
  • Planned treatment with stereotactic radiosurgery (SRS) as per the treating physician team
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Individuals of reproductive potential must use two highly effective forms of contraception for at least 4 weeks prior to screening and during study participation up to 1 week after the last 18F-fluciclovine PET
Not Eligible

You will not qualify if you...

  • Prior anaphylactic reaction to 18F-fluciclovine
  • Radiographic evidence of leptomeningeal disease
  • Prior whole-brain radiation therapy
  • Inability to undergo MRI (e.g., presence of pacemaker)
  • Pregnant or positive serum pregnancy test within 14 days of registration
  • Expecting to be breastfeeding at time of 18F-fluciclovine PET and unwilling to stop breastfeeding for 24 hours
  • Major medical illness or psychiatric/cognitive impairments preventing protocol completion or informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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 Kotecha, M.D.

CONTACT

A

Antoinette Pimental

CONTACT

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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