Using an optical probe to improve needle biopsy procedures

Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures

This study is testing a new optical probe to see if it can help doctors find tumor tissue better before doing a needle biopsy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06199492 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the feasibility of an investigational optical coherence tomography (OCT) probe designed to identify tumor tissue prior to core needle biopsy. The primary objective is to successfully place the optical probe through the guidance needle and capture high-quality images of the tumor morphology. Additionally, the study will assess the correlation between OCT imaging results and histopathology findings, as well as the ability of artificial intelligence to accurately classify tissue types based on the OCT images.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a primary or suspected diagnosis of malignancy and radiographic evidence of malignant lesions suitable for image-guided biopsy.

Not a fit: Patients without a confirmed or suspected malignancy or those with lesions not amenable to image-guided biopsy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the accuracy of tumor identification during biopsies, potentially leading to better patient outcomes.

How similar studies have performed: While the use of imaging technologies in biopsy procedures is not entirely novel, the specific application of OCT combined with AI for this purpose is relatively untested.

Eligibility criteria

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

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Rahul A Sheth, MD — M.D. Anderson Cancer Center
• Study coordinator: Rahul A Sheth, MD

Conditions: Needle Biopsy