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

NCT03295695 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: MCC-19220
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Cancer, Female; Breast Cancer, Male; Breast Neoplasms

Keywords

Chemotherapy induced cardiotoxicity; Tumor blood perfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Concordance Between FDG-RBC PET-CT and Echocardiogram

  Pre-treatment and Post-treatment, up to 12 months

Study Arms (1)

Cardiac Imaging - All Participants

EXPERIMENTAL

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.

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

Interventions

Fluoro-D-glucose-positron Emission Tomography DIAGNOSTIC_TEST

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.

Also known as: FDG-RBC PET-CT scan, Cardiac blood pool imaging

Cardiac Imaging - All Participants

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

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.

Also known as: FDG-labeled RBCs, 18F-fluorodeoxyglucose (FDG)-labeled human erythrocytes

Cardiac Imaging - All Participants

Echocardiogram DIAGNOSTIC_TEST

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

Also known as: Echocardiography

Cardiac Imaging - All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Fluorodeoxyglucose F18; Echocardiography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Jung Choi, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 28, 2017
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: December 4, 2020

Record last verified: 2020-12

Locations

US (1)