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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of cancer with radiographic finding of brain metastasis

• Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension

• Planned treatment with SRS as per the treating physician team

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET

Locations
United States
Florida
Miami Cancer Institute
RECRUITING
Miami
Contact Information
Primary
Rupesh Kotecha, M.D.
RupeshK@baptisthealth.net
(786) 596-2000
Backup
Antoinette Pimental
Antoinette.Pimentel@baptisthealth.net
(786) 596-2000
Time Frame
Start Date: 2024-04-11
Estimated Completion Date: 2027-05
Participants
Target number of participants: 46
Treatments
Experimental: 18F-Fluciclovine PET Imaging
Participants will undergo a 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging (MRI). Then participants will undergo single-fraction SRS as standard of care (SOC). A second 18F-fluciclovine PET scan will be completed 8 weeks (± 2 weeks) after SRS.
Related Therapeutic Areas
Sponsors
Collaborators: Blue Earth Diagnostics
Leads: Baptist Health South Florida

This content was sourced from clinicaltrials.gov