Clinical trial NCT03295695: 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
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Breast Cancer, Female
Breast Cancer, Male
Breast Neoplasms
Keywords: Chemotherapy induced cardiotoxicity
Tumor blood perfusion
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Cardiac Ejection Fraction (EF)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Concordance Between FDG-RBC PET-CT and Echocardiogram
timeFrame: Pre-treatment and Post-treatment, up to 12 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Jung Choi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: