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Artificial Intelligence (AI) Cytopathology Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05018663
Recruitment Status : Recruiting
First Posted : August 24, 2021
Last Update Posted : September 16, 2021
Information provided by (Responsible Party):
Nirav C Thosani, The University of Texas Health Science Center, Houston

Brief Summary:

Purpose The primary objective of the study is to compare interpretation of EUS FNA/FNB samples for adequacy between ROSE and AI at bedside. To compare accuracy of preliminary diagnosis results between ROSE and AI at bedside versus final pathology report.

Research design This is a prospective single center study to compare performance characteristics in the interpretation of EUS FNA/FNB samples between AI and ROSE.

Procedures to be used Eligible patients will undergo EUS guided FNA/FNA of PSLs using standard of care. Sample slides are prepared by a cytopathologist at bedside and observed under a microscope. At the same time, the slides are scanned using a slide scanner and those images are saved for interpretation by AI at a later time.

Condition or disease Intervention/treatment
Pancreatic Solid Lesions Other: Artificial Intelligence software ROSE

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Artificial Intelligence for Rapid On-site Evaluation (AI-ROSE) for Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) Biopsy of Pancreatic Solid Lesions: A Prospective Double Blinded Study
Actual Study Start Date : July 21, 2021
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : January 30, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
Prospective enrollment
All subjects will be enrolled prospectively. Subjects will be included in the study after eligibility is assessed and informed consent is obtained. The slide scanner will scan the slides on site and the images will be securely saved and sent for interpretation by the AI software at a different location. The results of the AI interpretation of the slides will be blinded to the on-site procedure team including the endoscopist and cytopathologist until the final pathology report is complete.
Other: Artificial Intelligence software ROSE
Rapid on-site evaluation (ROSE) of Endoscopic Ultrasound (EUS) guided FNA/FNB (Fine Needle Aspirate/Fine Needle Biopsy) of pancreatic solid lesions (PSLs) has been shown in improve diagnostic yield. The availability and performance of ROSE at EUS performing centers is variable. With strides in Artificial Intelligence (AI) capabilities over the years, the University of Texas at Health Sciences Center at Houston in collaboration with Haystac is developing an artificial intelligence based proprietary system to analyze slides from EUS FNA/FNB samples at bedside.

Primary Outcome Measures :
  1. Detection the adequacy for diagnosis [ Time Frame: During procedure ]
    The primary outcome of the study is to determine how AI compares with ROSE in determining if EUS FNA/FNB sample from PSLs is adequate for diagnosis. This will be interpreted as a percentage in each group. The main study parameter is on-site determination if an EUS FNA/FNB sample is adequate for interpretation and diagnosis

Secondary Outcome Measures :
  1. Comparing the accuracy between preliminary diagnosis [ Time Frame: During procedure ]

    To compare the accuracy between AI and ROSE preliminary diagnosis versus the final pathology report.

    Interpretation of preliminary results will be divided into categories of benign vs malignancy, acinar cells vs ductal cells in benign, adenocarcinoma vs neuroendocrine tumor vs other in malignancy.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be selected from the inpatients and outpatients departments of the participating hospital and will be included in the study. A consent will be obtained for the EUS FNA/FNB per standard of care.

Inclusion Criteria:

  • Have EUS finding of a PSL;
  • Do not have contraindications for FNA/FNB.

Exclusion Criteria:

  • Inability to provide informed consent for the procedure;
  • Contraindication for FNA/FNB eg coagulopathy, lack of avascular window for FNA.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05018663

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Contact: Prithvi B Patil, MS 7135006456

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United States, Texas
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Prithvi B Patil    713-480-1179   
Contact: Prithvi Patil, MS    7135006456   
Principal Investigator: Nirav Thosani, MD,MHA         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
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Principal Investigator: Nirav Thosani, MD, MHA The University of Texas Health Science Center, Houston
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Responsible Party: Nirav C Thosani, Associate Professor, The University of Texas Health Science Center, Houston Identifier: NCT05018663    
Other Study ID Numbers: HSC-MS-21-0051
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nirav C Thosani, The University of Texas Health Science Center, Houston:
Endoscopic Ultrasound guided fine needle aspiration (FNA)
Endoscopic Ultrasound guided fine needle biopsy (FNB)