Status:
WITHDRAWN
PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Breast Cancer
Breast Cancer, Female
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03295695
Start Date
December 1 2020
End Date
December 1 2022
Last Update
December 4 2020
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612