Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT06268405
Status:
RECRUITING
Last Update Posted:
2024-10-01
First Post:
2024-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Breast Cancer Combined Visualization And Characterization Tools - Novel Positron Emission Mammography System and Liquid Biopsy
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The goal of this research study is to evaluate the performance of two experimental tests, namely Liquid Biopsy and Positron Emission Mammography (PEM) in women at high risk of breast cancer. The plan for this study is to assess whether findings from the combination or each individual test can assist radiologists in visualizing and characterizing beast abnormalities.
Liquid Biopsy is a blood test that can detect early tumours in patients with malignancies, while PEM is an imaging tool equipped with a high-resolution camera that uses a low dose of injected positron emitting isotope to locate breast tumours. Participation in this study entails a blood draw for Liquid Biopsy test and a PEM imaging exam before undergoing a magnetic resonance imaging (MRI) - guided biopsy for a suspicious breast lesion.
If PEM and/or Liquid Biopsy provide accurate information to assist radiologists in visualizing and characterizing breast abnormalities, this method may serve as the first step towards establishing these genomic and new imaging technologies as new diagnostic modalities and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations.
Liquid Biopsy is a blood test that can detect early tumours in patients with malignancies, while PEM is an imaging tool equipped with a high-resolution camera that uses a low dose of injected positron emitting isotope to locate breast tumours. Participation in this study entails a blood draw for Liquid Biopsy test and a PEM imaging exam before undergoing a magnetic resonance imaging (MRI) - guided biopsy for a suspicious breast lesion.
If PEM and/or Liquid Biopsy provide accurate information to assist radiologists in visualizing and characterizing breast abnormalities, this method may serve as the first step towards establishing these genomic and new imaging technologies as new diagnostic modalities and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: