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

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Withdrawn; Early Phase 1

Conditions: Breast Cancer; Breast Cancer, Female; Breast Neoplasms; Breast Cancer, Male

Treatments: Diagnostic Test: Fluoro-D-glucose-positron Emission Tomography; Biological: 2-deoxy-2-[18F]fluoro-D-glucose (FDG); Diagnostic Test: Echocardiogram

Study type: Interventional

Funder types: Other

Identifiers

NCT03295695

MCC-19220

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Cardiac Imaging - All Participants

Experimental group

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.

Treatment:

Biological: 2-deoxy-2-[18F]fluoro-D-glucose (FDG)

Diagnostic Test: Echocardiogram

Diagnostic Test: Fluoro-D-glucose-positron Emission Tomography