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

Baptist Health South Florida

Status and phase: Enrolling; Phase 1

Conditions: Brain Metastases, Adult; Brain Metastases; Brain Cancer

Treatments: Drug: 18F fluciclovine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06048094

2022-KOT-003

Details and patient eligibility

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

18F-Fluciclovine PET Imaging

Experimental group

Description:

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.

Treatment:

Drug: 18F fluciclovine