Clinical trial NCT04689048: Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery
Official title: Characterization of Large Brain Metastases With 18F-Fluciclovine PET/CT Treated With Staged Stereotactic Radiosurgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Brain Metastases, Adult
Brain Metastases
Brain Cancer
Keywords: brain
brain metastases
brain metastases, adult
brain cancer
Stereotactic Radiosurgery
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
Collaborators: name: Blue Earth Diagnostics
First posted: 2020-12-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, single-site, single-arm, phase 1 proof-of-concept study to assess the potential clinical utility of 18F-fluciclovine PET/CT as a functional integral biomarker for patients with large brain metastases (\>2 cm) treated with Staged Stereotactic Radiosurgery (SSRS).
Primary purpose: PREVENTION

Brief summary: The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.


Eligibility criteria: Inclusion Criteria:

1. Male or female, age ≥18 years
2. Performance status, Eastern Cooperative Oncology Group 0-2
3. Confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter
4. Plan for SSRS per the treating team
5. For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
6. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-fluciclovine positron emission tomography/computerized tomography

Exclusion Criteria:

1. Prior anaphylactic reaction to 18F-fluciclovine
2. Evidence of leptomeningeal disease
3. Prior whole-brain radiation therapy
4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
5. Females pregnant at the expected time of 18F-fluciclovine administration
6. Females who are expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed
7. Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent

Primary outcomes:
measure: Change in sensitivity for PET/CT
timeFrame: through study completion, an average of 1 year
measure: Change in sensitivity for MRI
timeFrame: through study completion, an average of 1 year
measure: Change in the standardized uptake value (SUV) parameters
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Compare change of SUV metrics of 18F-fluciclovine PET
timeFrame: baseline
measure: Compare change of SUV metrics of contrast-enhanced MRI
timeFrame: baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
Study officials:
affiliation: Miami Cancer Institute (MCI) at Baptist Health, Inc.
name: Rupesh R Kotecha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.