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

This study is not yet open for participant recruitment.
Verified October 2017 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT03295695
First Posted: September 28, 2017
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
  Purpose

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.


Condition Intervention Phase
Breast Cancer Breast Cancer, Female Breast Cancer, Male Breast Neoplasms Diagnostic Test: Fluoro-D-glucose-positron Emission Tomography Biological: 2-deoxy-2-[18F]fluoro-D-glucose (FDG) Diagnostic Test: Echocardiogram Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study of PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient Before and After Neoadjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Cardiac Ejection Fraction (EF) [ Time Frame: Up to 12 months ]
    Calculated cardiac ejection fraction (EF) with a low radiation dose FDG-RBC PET-computed tomography (CT) scan before and after neoadjuvant chemotherapy.


Secondary Outcome Measures:
  • Concordance Between FDG-RBC PET-CT and Echocardiogram [ Time Frame: Pre-treatment and Post-treatment, up to 12 months ]
    The concordance will be estimated by the use of Lin's method49 along with 95% confidence interval.


Estimated Enrollment: 10
Anticipated Study Start Date: January 2018
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardiac Imaging - All Participants
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
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.
Other Names:
  • FDG-RBC PET-CT scan
  • Cardiac blood pool imaging
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.

Other Names:
  • FDG-labeled RBCs
  • 18F-fluorodeoxyglucose (FDG)-labeled human erythrocytes
Diagnostic Test: Echocardiogram
Echocardiogram: prior to start of chemotherapy; post-treatment regimen.
Other Name: Echocardiography

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295695


Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Malesa Pereira    813-745-4090    malesa.pereira@moffitt.orgm   
Contact: Jung Choi, M.D.    813-745-2058    jung.choi@moffitt.org   
Principal Investigator: Jung Choi, M.D.         
Sub-Investigator: Kenneth Gage, M.D., Ph.D.         
Sub-Investigator: Roohi Ismail-Khan, M.D.         
Sub-Investigator: Daniel Jeong, M.D.         
Sub-Investigator: Jaime Montilla-Soler, M.D.         
Sub-Investigator: Hatem Soliman, M.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Jung Choi, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03295695     History of Changes
Other Study ID Numbers: MCC-19220
First Submitted: September 25, 2017
First Posted: September 28, 2017
Last Update Posted: October 24, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Chemotherapy induced cardiotoxicity
Tumor blood perfusion

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action