New device aims to make cancer biopsies more precise
NCT ID NCT06199492
First seen Jun 26, 2026 · Last updated Jul 17, 2026 · Updated 3 times
Summary
This study tests a new imaging device called tVisio-1 that helps doctors see tumor tissue before taking a biopsy sample. The goal is to make biopsies more accurate and reduce complications. About 150 adults with suspected or confirmed cancer will participate at MD Anderson Cancer Center.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tVisio-1 imaging device
- What this could lead to
- If successful, this device could make biopsies more accurate by helping doctors target tumor tissue directly, potentially reducing the need for repeat procedures.
- What could go wrong
- This is an early-stage feasibility study with only 150 participants, so the device may not prove more effective than standard methods. There is also a risk of device-related adverse events.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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