- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03295695
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
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 Overview
Status
Study Type
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants must have histologically confirmed breast cancer and be scheduled for neoadjuvant Trastuzumab- or anthracycline-based chemotherapy.
- 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:
- Prior history of invasive breast cancer and treatment with anthracycline chemotherapy.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 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.
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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.
Other Names:
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.
Other Names:
Echocardiogram: prior to start of chemotherapy; post-treatment regimen.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Ejection Fraction (EF)
Time Frame: Up to 12 months
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Calculated cardiac ejection fraction (EF) with a low radiation dose FDG-RBC PET-computed tomography (CT) scan before and after neoadjuvant chemotherapy.
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Up to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concordance Between FDG-RBC PET-CT and Echocardiogram
Time Frame: Pre-treatment and Post-treatment, up to 12 months
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The concordance will be estimated by the use of Lin's method49 along with 95% confidence interval.
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Pre-treatment and Post-treatment, up to 12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Jung Choi, M.D., H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-19220
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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