Needle BiopsyNCT06199492
Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures
A study testing tVisio-1 in people with Needle Biopsy, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if an investigational imaging device can help to identify tumor tissue before a biopsy is taken. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Needle Biopsy
- What is being tested?
- tVisio-1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Rahul A Sheth, MD, 713-745-0652, rasheth@mdanderson.org
Rahul A Sheth, MD
About this study
To learn if an investigational imaging device can help to identify tumor tissue before a biopsy is taken.
Read the 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
- Being tested
- tVisio-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tVisio-1Device
Standard of Care Biopsy
| Study group | Role | What they receive |
|---|---|---|
| tVisio-1 | Experimental | 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. Receives: Device: tVisio-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start5 Dec 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Needle BiopsyStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rahul A Sheth, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199492
- Sponsor's protocol ID
- 2023-0117
- Other IDs
- NCI-2023-11126
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures
- ClinicalTrials.gov ID
- NCT06199492
- Acronym / sponsor ID
- 2023-0117
- Conditions
- Needle Biopsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tVisio-1 | Experimental | Device: tVisio-1The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tVisio-1Standard of Care Biopsy | Device | tVisio-1 |
Primary outcome
Safety and adverse events (AEs)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rahul A Sheth, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tVisio-1 in people with Needle Biopsy, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahul A Sheth, MD ((713) 745-0652, rasheth@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.