Trials / Withdrawn
WithdrawnNCT03295695
PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient
Pilot Study of PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient Before and After Neoadjuvant Chemotherapy
- Status
- Withdrawn
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2021-12-01
- Completion
- 2022-12-01
- First posted
- 2017-09-28
- Last updated
- 2020-12-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03295695. Inclusion in this directory is not an endorsement.