Back to resultsPET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient
Primary Purpose
Breast Cancer, Breast Cancer, Female, Breast Cancer, Male
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fluoro-D-glucose-positron Emission Tomography
2-deoxy-2-[18F]fluoro-D-glucose (FDG)
Echocardiogram
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Chemotherapy induced cardiotoxicity, Tumor blood perfusion
Eligibility Criteria
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.
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cardiac Imaging - All Participants
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03295695
First Posted
September 25, 2017
Last Updated
December 3, 2020
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03295695
Brief Title
PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient
Official Title
Pilot Study of PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient Before and After Neoadjuvant Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
closure of radiolaboratory
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Cancer, Female, Breast Cancer, Male, Breast Neoplasms
Keywords
Chemotherapy induced cardiotoxicity, Tumor blood perfusion
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac Imaging - All Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Fluoro-D-glucose-positron Emission Tomography
Other Intervention Name(s)
FDG-RBC PET-CT scan, Cardiac blood pool imaging
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
2-deoxy-2-[18F]fluoro-D-glucose (FDG)
Other Intervention Name(s)
FDG-labeled RBCs, 18F-fluorodeoxyglucose (FDG)-labeled human erythrocytes
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Echocardiogram
Other Intervention Name(s)
Echocardiography
Intervention Description
Echocardiogram: prior to start of chemotherapy; post-treatment regimen.
Primary Outcome Measure Information:
Title
Cardiac Ejection Fraction (EF)
Description
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
Secondary Outcome Measure Information:
Title
Concordance Between FDG-RBC PET-CT and Echocardiogram
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Choi, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Links:
URL
https://moffitt.org/clinical-trials-research/
Description
Moffitt Cancer Center Clinical Trials website
Learn more about this trial
PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient
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