Viewing Study NCT03295695


Ignite Creation Date: 2025-12-24 @ 1:42 PM
Ignite Modification Date: 2026-02-11 @ 3:55 AM
Study NCT ID: NCT03295695
Status: WITHDRAWN
Last Update Posted: 2020-12-04
First Post: 2017-09-25
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Organization:

Study Overview

Official Title: Pilot Study of PET-CT Imaging Using FDG-labeled Human Erythrocytes in Breast Cancer Patient Before and After Neoadjuvant Chemotherapy
Status: WITHDRAWN
Status Verified Date: 2020-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: closure of radiolaboratory
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: