PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient



Status:Not yet recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:June 2019
End Date:March 2022

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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.


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.
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Jung Choi, M.D.
Phone: 813-745-4090
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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mi
from
Tampa, FL
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