PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient
NCT ID: NCT03295695
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2020-12-31
2022-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Cardiac Imaging - All Participants
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.
Fluoro-D-glucose-positron Emission Tomography
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)
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.
Echocardiogram
Echocardiogram: prior to start of chemotherapy; post-treatment regimen.
Interventions
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Fluoro-D-glucose-positron Emission Tomography
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)
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.
Echocardiogram
Echocardiogram: prior to start of chemotherapy; post-treatment regimen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky \>60%).
* Must be able to complete an informed consent process.
* Must have normal organ and marrow function: leukocytes \>3,000/μL; absolute neutrophil count \>1,500/μL; platelets \>100,000/μL; total bilirubin within normal institutional limits; aspartate aminotransferase (AST)\[SGOT\] / alanine aminotransferase (ALT)\[SGPT\]: less than 2.5 X institutional upper limit of normal; Creatinine within normal institutional limits - OR - creatinine clearance\>60 mL/min/1.73 m\^2 for patients with creatinine level above institutional normal.
* Echocardiogram results should be of sufficiently suitable quality (adequate acoustic window access) to provide a reliable ejection fraction range calculation. The cardiac ejection fraction on the pre-treatment echocardiogram should be 50% or higher.
* Participants should be naïve to Trastuzumab or anthracycline chemotherapy prior to enrollment.
Exclusion Criteria
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to FDG.
* Known symptomatic coagulopathies, bleeding diathesis, hemoglobinopathies, or hemolytic anemia.
* Participants should have no clinically significant heart disease such as congestive heart failure. Participants should not have other significant structural heart disease by echocardiogram, or cardiac dysrhythmia on standard of care electrocardiogram that may adversely affect the cardiac imaging results obtained with FDG-RBC PET-CT imaging.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Women who are pregnant.
* Found to have a cardiac ejection fraction less than 50% on the pre-treatment echocardiogram.
18 Years
ALL
No
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Jung Choi, M.D.
Role: PRINCIPAL_INVESTIGATOR
H. Lee Moffitt Cancer Center and Research Institute
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Countries
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Other Identifiers
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MCC-19220
Identifier Type: -
Identifier Source: org_study_id