PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient
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|ClinicalTrials.gov Identifier: NCT03295695|
Recruitment Status : Not yet recruiting
First Posted : September 28, 2017
Last Update Posted : March 29, 2018
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 or disease||Intervention/treatment||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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|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|
|Estimated Study Start Date :||June 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
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.
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.
Other Name: Echocardiography
- 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.
- 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.
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
|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 firstname.lastname@example.org|
|Contact: Jung Choi, M.D. 813-745-2058 email@example.com|
|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.|
|Principal Investigator:||Jung Choi, M.D.||H. Lee Moffitt Cancer Center and Research Institute|