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

Phase 1RecruitingNCT06048094

Baptist Health South Florida46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Brain Metastases Brain Metastases, Adult Brain Cancer

Interventions

18F fluciclovineDRUG

Participants will receive 5-mCi dose (± 20%) of 18F-fluciclovine intravenously as a bolus injection immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Miami Cancer Institute

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Standardized Uptake Value (SUV)-peak

Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVpeak will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.

Time frame: 8 weeks

Change in SUVmean

Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmean will be calculated for the pre-SRS and post-SRS imaging studies, as well as the percent change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.

Time frame: 8 weeks

Change in SUVmax

Each 18F-fluciclovine PET will undergo quantitative image analysis by the study nuclear medicine physician. The lesion on each PET will be correlated with the lesion on the corresponding contrast-enhanced MRI and will be delineated. The SUVmax will be calculated for the pre-SRS and post-SRS imaging studies, as well as the change from pre to post will be calculated. Assuming SRS reduces the tumor size, a negative percent change (decrease) is expected.

Time frame: 8 weeks

Secondary Outcomes

Tumor Control

Each lesion will be followed from pre-treatment PET to local failure or retreatment; death; lost-to follow-up, discontinuation, or withdrawal; or end of study. Local failure is defined as disease progression according to Response Assessment in Neuro-Oncology (RANO) criteria.

Time frame: 12 months

Central Contacts

Rupesh Kotecha, M.D.

CONTACT

(786) 596-2000 RupeshK@baptisthealth.net

Kristy Reyes

CONTACT

(786) 596-2000 Kristina.Reyes@baptisthealth.net

Data from ClinicalTrials.gov

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