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Breast Neoplasms

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Breast Neoplasms, Male

Breast Diseases

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Breast Cancer, Male

All Drugs and Chemicals

Fluorodeoxyglucose F18

Radiopharmaceuticals

Study agent: 2-deoxy-2-\[18F\]fluoro-D-glucose (FDG). Fluoro-D-glucose-positron Emission Tomography: Participants will undergo a PET-CT scan with Fluoro-D-glucose-labeled (FDG-labeled) red blood cells (RBCs) within 2 weeks of obtaining an echocardiogram prior to start of chemotherapy. A repeat FDG-RBC PET-CT scan will be completed within two weeks of obtaining their follow-up echocardiogram to determine post-therapy cardiac ejection fraction. If the participant has an echocardiogram obtained prior to completion of chemotherapy, an attempt will be made to obtain a FDG-RBC PET-CT scan within two weeks of the echocardiogram.

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.

Fluoro-D-glucose-positron Emission Tomography

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.

2-deoxy-2-[18F]fluoro-D-glucose (FDG)

Echocardiogram: prior to start of chemotherapy; post-treatment regimen.

Echocardiogram

Jung Choi, M.D.

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.

PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient

Pilot Study of PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient Before and After Neoadjuvant Chemotherapy

Calculated cardiac ejection fraction (EF) with a low radiation dose FDG-RBC PET-computed tomography (CT) scan before and after neoadjuvant chemotherapy.

The concordance will be estimated by the use of Lin's method49 along with 95% confidence interval.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient	NCT03295695	Breast Cancer Breast Cancer, ... Breast Cancer, ... Breast Neoplasm...	Fluoro-D-glucos... 2-deoxy-2-[18F]... Echocardiogram	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient	NCT03295695	Breast Cancer Breast Cancer, ... Breast Cancer, ... Breast Neoplasm...	Fluoro-D-glucos... 2-deoxy-2-[18F]... Echocardiogram	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for breast cancer, female