Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06199492
Status
Recruiting
Apply to this trial

Conditions

  • Needle Biopsy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tVisio-1 — DEVICE
    Standard of Care Biopsy

Study Details

To learn if an investigational imaging device can help to identify tumor tissue before a biopsy is taken.

Key Dates

Start date
Dec 5, 2024
Status verified
Jan 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: tVisio-1
    The device collects optical coherence tomography (OCT) images in an effort to identify tumor tissue before physical samples are collected. During the biopsy, a sterilized optical imaging probe will be placed through the standard biopsy guidance needle to collect a few images of the tissue at the tip of the biopsy needle. Then the regular biopsy will continue to collect a few biopsy cores.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Rahul A Sheth, MD
[email protected]
713-745-0652
Rahul A Sheth, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By research site
MD Anderson Cancer Center· Houston, TX