Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04016818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-24
First Post:
2019-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Pilot Study of a Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a research study of a novel, "breast-dedicated" positron emission tomography (PET) camera with 1 millimeter spatial resolution. The main goal of the study is for the personnel to understand practical and logistical issues with using the camera in the clinic
Detailed Description:
Primary Objective To obtain initial experience using the novel, breast-dedicated PET camera design in the breast imaging clinic.
Secondary Objectives To understand, given the 10-fold higher sensitivity of this novel camera, how low we can go with administered tracer dose, and, given the \>100-fold better volumetric spatial resolution, understand the achievable image quality.
Secondary Objectives To understand, given the 10-fold higher sensitivity of this novel camera, how low we can go with administered tracer dose, and, given the \>100-fold better volumetric spatial resolution, understand the achievable image quality.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: