Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT05554133
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2022-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Precision Optical Guidance for Oral Biopsy
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Precision Optical Guidance for Oral Biopsy Based on Next-Generation Hallmarks of Cancer (1R01DE029590-01): A Clinical Study to Evaluate and Optimize the Technical Performance Characteristics of an Active Biopsy Guidance System
Status:
RECRUITING
Status Verified Date:
2025-08
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 a new type of imaging device called the Active Biopsy Guidance System can help doctors to decide when and where to perform invasive biopsies of mouth lesions.
Detailed Description:
Primary objective:
-To evaluate and optimize the technical performance characteristics of an Active Biopsy Guidance System.
Secondary objective:
-To provide a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology. Optical imaging; optical projection of light onto tissue; optical contrast agent (proflavine).
-To evaluate and optimize the technical performance characteristics of an Active Biopsy Guidance System.
Secondary objective:
-To provide a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology. Optical imaging; optical projection of light onto tissue; optical contrast agent (proflavine).
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-07929 | OTHER | NCI-CTRP Clinical Trials Registry | View | |
| R01DE029590-01 | NIH | None | https://reporter.nih.gov/quic… | View |