This is a single arm, phase 0 study to evaluate the safety and efficacy of PET-CT scans with FDG-labeled RBC in patients with breast cancer. Cardiac ejection fraction can be calculated and monitored in breast cancer patients during chemotherapy using a FDG-RBC PET-CT scan. The purpose of this study is to determine if calculated cardiac ejection fraction shows high concordance with results from echocardiography.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
2-deoxy-2-\[18F\]Fluoro-D-glucose-positron Emission Tomography (FDG-PET): within 2 weeks of obtaining first echocardiogram; within two weeks of obtaining follow-up echocardiogram.
2-deoxy-2-\[18F\]fluoro-D-glucose (FDG) labeled autologous human erythrocytes (RBCs): Approximately 10 mls of packed human erythrocytes are collected from the patient and labeled with ≈5-10 milliCuries of commercially available United States Pharmacopeia (USP)-grade FDG (≈5-10 picograms FDG) (Vendor: Cardinal Health) under sterile conditions in a Good Manufacturing Practice (GMP)-certified laboratory. Synthesized RBCs: The cell suspension is manually infused via syringe through an indwelling peripheral venous catheter over the course of 1 minute, using an infusion method approved by the Moffitt Cancer Center (MCC) radiation safety officer.
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Cardiac Ejection Fraction (EF)
Calculated cardiac ejection fraction (EF) with a low radiation dose FDG-RBC PET-computed tomography (CT) scan before and after neoadjuvant chemotherapy.
Time frame: Up to 12 months
Concordance Between FDG-RBC PET-CT and Echocardiogram
The concordance will be estimated by the use of Lin's method49 along with 95% confidence interval.
Time frame: Pre-treatment and Post-treatment, up to 12 months
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Echocardiogram: prior to start of chemotherapy; post-treatment regimen.