Status:
RECRUITING
18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery
Lead Sponsor:
Baptist Health South Florida
Collaborating Sponsors:
Blue Earth Diagnostics
Conditions:
Brain Metastases
Brain Metastases, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 tom...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Prior anaphylactic reaction to 18F-fluciclovine
- Radiographic evidence of leptomeningeal disease
- Prior whole-brain radiation therapy
- Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)
- Pregnant or positive serum pregnancy test within 14 days of registration
- Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 24 hours after the time of imaging is allowed.
- Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol and/or preclude informed consent\*
- A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.
Key Trial Info
Start Date :
April 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06048094
Start Date
April 11 2024
End Date
May 1 2027
Last Update
May 18 2025
Active Locations (1)
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1
Miami Cancer Institute
Miami, Florida, United States, 33176