Clinical Trial · NCT06015295

A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy

Overview

To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain metastatic lesions in patients who are receiving immunotherapy.

Sponsor

MD Anderson Cancer Center

Phase

N/A

Contacts

Yang Lu, MD (CONTACT)

ylu10@mdanderson.org

(713) 792-5768

ClinicalTrials.gov

Drug / Compound

Isotope(s):

Target(s):

Ligand Class: Small Molecules

Eligibility

Willingness to participate in the study and ability to provide written informed consent.
Patients must have documented brain metastatic lesion(s) in the medical record.
1. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of Axumin in pediatric patients, patients \<18 years of age are excluded from this study.
ECOG performance status ≤2 (Karnofsky ≥60%,).
On active immunotherapy for the diagnosed malignancy. Concurrent other treatment is allowed. Immunotherapy and other treatment regimens are determined by treating physicians as per standard clinical practice.

1. Pregnant or breastfeeding during participation in the study are excluded because: There is no information on the risk of adverse developmental outcomes in pregnant women or animals with the use of Fluciclovine F18. All radiopharmaceuticals, including Axumin, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose; There is no information on the presence of Fluciclovine F18 in human milk, the effect on the breastfed infant, or the effect on milk production.
Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Unable to lie flat during or tolerate PET-CT
History of severe allergic reactions to Axumin PET radiopharmaceuticals. Mild to moderate reactions that can be controlled by medications prior to the scheduled PET/CT are acceptable.
Contraindications to Axumin Injection have not been established in humans. None are known or have been observed in nonclinical or clinical studies performed to date.