Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-02 @ 1:13 AM
Study NCT ID:
NCT03987568
Status:
WITHDRAWN
Last Update Posted:
2022-12-21
First Post:
2019-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterize Tumor Hypoxia by Magnetic Resonance Imaging
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
To Characterize Tumor Hypoxia by Magnetic Resonance Imaging in African American and Caucasian Prostate Cancer Patients
Status:
WITHDRAWN
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Issues in reserving MRI scanner
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to measure the hypoxia (low oxygen condition) in prostate cancers and its effect in survival. In this study, investigators will assess hypoxia by magnetic resonance imaging (MRI) and create a hypoxia score. Investigators will study the hypoxia score and how it correlates (if any) to the disease aggressiveness as well as its effect on the treatment outcomes.
Detailed Description:
Primary Objective(s):
* To assess hypoxia in primary prostate tumors by magnetic resonance imaging.
* To correlate hypoxic score with disease aggressiveness (proliferation biomarkers' expression).
Secondary Objective(s):
* To correlate hypoxic score with ExoHypoxic concentration in plasma of same patient.
* To correlate hypoxic score with fatty acid synthase (FASN) expression.
* To assess hypoxia in primary prostate tumors by magnetic resonance imaging.
* To correlate hypoxic score with disease aggressiveness (proliferation biomarkers' expression).
Secondary Objective(s):
* To correlate hypoxic score with ExoHypoxic concentration in plasma of same patient.
* To correlate hypoxic score with fatty acid synthase (FASN) expression.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| WFBCCC 03319 | OTHER | Wake Forest Baptist Comprenhensive Cancer Center | View | |
| P30CA012197 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2019-04690 | OTHER | National Cancer Institute | View |