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

Breast Cancer Clinical Trial

Official title:

Pilot Study of PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient Before and After Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03295695
• Other study ID #: MCC-19220
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: December 2020
• Est. completion date: December 2022

Study information

• Verified date: December 2020
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer, Female
• Breast Cancer, Male
• Breast Neoplasms
• Breast Neoplasms, Male

Intervention

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

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

Diagnostic Test:
• Echocardiogram
Echocardiogram: prior to start of chemotherapy; post-treatment regimen.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months
Secondary	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.	Pre-treatment and Post-treatment, up to 12 months

External Links

•   Moffitt Cancer Center Clinical Trials website