Ignite Creation Date:
2024-05-06 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05055843
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2021-07-21
Brief Title:
Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Screening Prostate Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Novel Synthetic T2W MR Imaging and Spin Parameter Mapping Techniques for Prostate Cancer Without an Endorectal Coil
Status:
ACTIVE_NOT_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:
This clinical trial studies examines a 3D magnetic resonance imaging MRI compared to standard MRI imaging techniques in screening patients with prostate cancer Diagnostic procedures such as MRI may help find and diagnose prostate cancer Computer systems that allow doctors to create a 3-dimensional 3-D picture of the tumor may help in planning
Detailed Description:
PRIMARY OBJECTIVE
I To determine whether the image quality of the novel 3-dimensional 3D T2-weighted imaging T2W synthetic imaging technique without endorectal coil is comparable to the 2-dimensional 2D T2W imaging technique without endorectal coil
SECONDARY OBJECTIVE
I To evaluate the qualitative diagnostic quality of the T2W images provided by the novel 3D technique as determined by subjective scoring by experienced readers
EXPLORATORY OBJECTIVE
I To investigate the feasibility of novel 3D synthetic imaging and multi-spin parameter mapping technique of prostate for the detection of clinically significant prostate cancer csPCa
OUTLINE
Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time
I To determine whether the image quality of the novel 3-dimensional 3D T2-weighted imaging T2W synthetic imaging technique without endorectal coil is comparable to the 2-dimensional 2D T2W imaging technique without endorectal coil
SECONDARY OBJECTIVE
I To evaluate the qualitative diagnostic quality of the T2W images provided by the novel 3D technique as determined by subjective scoring by experienced readers
EXPLORATORY OBJECTIVE
I To investigate the feasibility of novel 3D synthetic imaging and multi-spin parameter mapping technique of prostate for the detection of clinically significant prostate cancer csPCa
OUTLINE
Patients undergo 3D MRI imaging over 15 minutes with standard of care MRI or at a separate time
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-0273 | OTHER | M D Anderson Cancer Center | None |
| NCI-2021-05282 | REGISTRY | None | None |