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Recruiting
NCT06199492
Intelligent Optical Probe for Guiding Core Needle Biopsy Procedures
Conditions: Needle Biopsy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: M.D. Anderson Cancer Center
Location: MD Anderson Cancer Center Houston Texas
Summary
To learn if an investigational imaging device can help to identify tumor tissue before a biopsy is taken.
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 \
Source: ClinicalTrials.gov (NCT06199492). StuddyBuddy aggregates publicly available trial information.