Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-02 @ 12:05 PM
Study NCT ID:
NCT06199492
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2023-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures
Status:
RECRUITING
Status Verified Date:
2025-07
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:
To learn if an investigational imaging device can help to identify tumor tissue before a biopsy is taken.
Detailed Description:
Primary Objectives
\- To determine the feasibility of using an OCT probe that will assess tumor morphology before taking a biopsy core needle. The endpoint for this objective will be the successful placement of the optical probe through the guidance needle and collection of high-quality optical coherence tomography images.
Secondary Objectives
* To assess if OCT imaging results correlate with histopathology findings.
* To assess if artificial intelligence can correctly assess tissue type based on OCT imaging.
\- To determine the feasibility of using an OCT probe that will assess tumor morphology before taking a biopsy core needle. The endpoint for this objective will be the successful placement of the optical probe through the guidance needle and collection of high-quality optical coherence tomography images.
Secondary Objectives
* To assess if OCT imaging results correlate with histopathology findings.
* To assess if artificial intelligence can correctly assess tissue type based on OCT imaging.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-11126 | OTHER | NCI-CTRP Clinical Registry | View |