NCT06199492

Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Needle Biopsy

Interventions

Type	Name	Description
DEVICE	tVisio-1	Standard of Care Biopsy

Timeline

• Start date: 2024-12-05
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2024-01-10
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States