Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Cardiotoxicity

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

All Drugs and Chemicals

Hormones

Patients who received anthracycline-based chemotherapy 3 months ago

Patients who received anthracycline-based chemotherapy 6 months ago

Patients who received anthracycline-based chemotherapy more than 1 year ago

Patients who have been treated with other therapies (other chemo-therapies, combined radiation therapy, target agent therapy, hormone therapy)

The cardiac imaging protocol will include pre-contrast T1, post-contrast T1, and T2 mapping images acquired of the mid ventricle with the short axis plane for the analysis of native T1, T2, and extracellular volume (ECV) values of the myocardium. It will also include cine imaging covering the whole LV myocardium in the short axis plane for a functional analysis of the LV myocardium.

Cardiac magnetic resonance imaging

Byoung Wook Choi, MD

Chemotherapy or radiation therapy-induced cardiotoxicity are well-recognized side effects in patients with cancer. The clinical significance of cardiotoxicity is growing with increasing cancer survivor-ship.

Left ventricular (LV) functional assessment is the standard of reference to diagnose chemotherapy- or radiation therapy-induced cardiotoxicity. The investigators will investigate the usefulness of T1 mapping parameters for early detection and prediction of chemotherapy-, radiation therapy-, or other therapy-induced cardiotoxicity in breast cancer patients This study aimed to achieve early detection of chemotherapy- or radiation therapy-induced cardiotoxicity using T1 mapping magnetic resonance imaging (MRI) and determine a prognostic imaging factor of chemotherapy- or radiation therapy-induced cardiotoxicity in patients treated for breast cancer.

Screening and follow-up cardiac magnetic resonance imaging (CMR) protocols for diagnosis of cardiotoxicity will be conducted in patients with breast cancer who have received or are planned to receive treatment for breast cancer. The protocol will include T1 and T2 mapping and cine imaging of the LV myocardium.

Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)

Decrease in LVEF : more than 10% compared to the baseline LVEF) or LVEF \< 50%

Yonsei University

Rare Diseases

Breast Neoplasms, Male

Breast Diseases

Skin Diseases

Breast Cancer, Male

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
Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)	NCT03301389	Chemotherapy In...	Cardiac magneti...	17 Years - 80 Years	Yonsei University
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
Cardiac Magnetic Resonance for Early Detection of Chemotherapy or Radiation Therapy Induced Cardiotoxicity in Breast Cancer (CareBest)	NCT03301389	Chemotherapy In...	Cardiac magneti...	17 Years - 80 Years	Yonsei University
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 chemotherapy induced cardiotoxicity