Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures

This study is looking at a new device called tVisio-1 to help doctors during a core needle biopsy. A biopsy is when a small piece of tissue is removed to be checked for disease. The tVisio-1 device uses light to create images of tissue, which might help doctors see if they are taking a sample from a tumor before the biopsy is fully taken. You might be able to join if you are 18 or older, have a suspected or confirmed cancer diagnosis, and need an image-guided biopsy of a lymph node, liver, or lung. The main goal is to see if the tVisio-1 device can successfully get clear images of the tissue. This study plans to enroll 150 people, but its current status is unclear.

Study design: This is an interventional study, meaning you will receive a specific intervention. It aims to enroll 150 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Your safety and any side effects will be checked throughout the study, which is expected to average 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures

Recruiting

NAAges 18+InterventionalDiagnostic

M.D. Anderson Cancer Center

~150 participants

Updated 2026-07-16 on ClinicalTrials.gov

What's tested:tVisio-1

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Safety and adverse events (AEs)

Measured over Through study completion; an average of 1 year

Conditions

Needle Biopsy

NCT06199492

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

MD Anderson Cancer Center
Houston, Texasstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Rahul A Sheth, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Rahul A Sheth, MD

[email protected]

(713) 745-0652

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Participants must have a primary diagnosis or suspected diagnosis of malignancy and radiographic evidence of malignant lesions involving lymph node, liver or lung for which the participant was referred to IR for image-guided biopsy.

A target lesion that meets the following criteria:

The target lesion must be amenable to image guided biopsy

The target lesion must be \>= 1cm to ensure that the collected images will have sufficient morphological content to run the OCT image analysis Note: The collected biopsy core for the proposed study will undergo H\&E staining and analysis. The AI model will determine the percentage of tumor and necrotic tissue in each image. Histology assessment will be made in the same manner to determine AI model outcome.

Age ≥ 18 years at the time of consenting

Life expectancy ≥ 3 months

Platelet count \>50,000/mm3 within 6 weeks of screening

INR \<1.5 within 6 weeks of screening

If taking antiplatelet or anticoagulation medication, it must be able to be discontinued 48 hours prior to the procedure or at the discretion of the PI (e.g., aspirin, ibuprofen, LMWH preparations)

ECOG performance status \<= 2 within 6 weeks of screening.

Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal participants. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization. Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization.

All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible.

Ability to understand and the willingness to sign a written informed consent document.

Exclusion

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator.

Absolute neutrophil count \<1000 mm3 within 6 weeks of screening

Active infection

What this trial measures

Safety and adverse events (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03

Trialytics