Welcome to CAP s IVM Webinar Series sponsored by the Personalized Health Care Committee

Transcription

1 Welcome to CAP s IVM Webinar Series sponsored by the Personalized Health Care Committee This webinar on In Vivo Microscopy is presented by Guillermo (Gary) Tearney, MD, PhD. Your host is Jill Kaufman, PhD. For comments about this webinar or suggestions for upcoming webinars, please contact Jill Kaufman at jkaufma@cap.org THE WEBINAR WILL BEGIN MOMENTARILY. ENJOY! 2012 College of American Pathologists. All rights reserved. 1

2 Place sub-brand here In Vivo Microscopy Guillermo (Gary) Tearney, MD, PhD September 11, 2013 cap.org v. #

3 Guillermo (Gary) Tearney, MD, PhD PhD in Electrical Engineering (MIT) MGH Pathologist Pioneer in IVM technology development and clinical validation Vice-chair of IVM Work Group 2012 College of American Pathologists. All rights reserved. 3

4 Disclaimer The College does not permit reproduction of any substantial portion of the material in this Webinar without its written authorization. The College hereby authorizes attendees of the CAP Webinar to use the PDF presentation solely for educational purposes within their own institutions. The College prohibits use of the material in the Webinar and any unauthorized use of the College s name or logo in connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services. Opinions expressed by the speaker are the speaker s own and do not necessarily reflect an endorsement by CAP of any organizations, equipment, reagents, materials or services used by participating laboratories College of American Pathologists. All rights reserved. 4

5 Disclosure Dr. Tearney has the following financial relationships with commercial interests to disclose: Consulting - Ninepoint Medical, Samsung, Merck Sponsored research - Canon, Ninepoint Medical, Samsung, ilumen, Air Liquide, Merck Royalties - Ninepoint Medical, Terumo, MIT 2012 College of American Pathologists. All rights reserved. 5

6 In Vivo Microscopy (IVM) Definition of IVM: A new field where microscopic images are obtained in real time from living patients - Technologies currently use light - Images may be rapidly acquired in 2D and 3D - Images may be obtained using instrumentation that can be inserted into endoscope accessory ports or as standalone imaging tools

7 Goals of IVM Guide the acquisition of targeted and more meaningful biopsies Screen entire organs for occult microscopic disease Obtain microscopic diagnoses when tissues cannot be easily or safely excised Assess the efficacy of therapy

8 Technologies Commercially available and FDA-approved Optical coherence tomography (OCT) Confocal microscopy - Confocal laser endomicroscopy (CLE) Volume laser endomicroscopy (VLE) Many other technologies used in research Material costs (estimates) Equipment: ~$50K-$250K Endoluminal probes: ~$100-$1000/use

9 Optical Coherence Tomography (OCT) Enables visualization of microscopic tissue architectural morphology Analogous to ultrasound, but uses light to achieve higher resolution Provides cross-sectional and 3D images 10 µm resolution in depth µm resolution in plane parallel to surface of tissue Contrast arises from scattering within tissue

10 Example: OCT cross-sectional OCT image of entire esophagus Epithelium Lamina propria Submucosa Muscularis propria Layered architecture

11 OCT Example: OCT image of Barrett s esophagus with high grade dysplasia OCT (in vivo) Histology Arrows point to atypical glands in the mucosa

12 Capsule IVM 500 µm 500 µm Capsule Tether stomach 1 cm Optics esophagus Normal Volunteer 2012 College of American Pathologists. All rights reserved. 12

13 Examples: OCT images of coronary arteries in vivo Thin-cap fibroatheroma In-stent restenosis Plaque rupture

14 Confocal Microscopy Enables visualization of microscopic tissue architectural and cellular morphology Provides 2D images in plane parallel to tissue surface (en face) 1-2 µm resolution 10 µm resolution in depth Contrast arises from scattering within tissue or from Fluorescein injected i.v.

15 Confocal Laser Endomicroscopy (CLE) Endoscopic microscopy microscopy through an endoscope Multiple forms: Probe-based CLE (pcle) Endoscope-based CLE (ecle) Needle-based CLE (ncle) - Probe inserted through the bore of a biopsy needle

16 pcle Examples Barrett s No Dysplasia Barrett s High-grade/IMC

17 ecle Example Histology image IVM image (in vivo) Kiesslich CGH,2006;4:979

18 Balloon Insertion 3D OCT IVM Dataset Identify Suspect Areas Guided Biopsy Paradigm Histopathology Biopsy at Marks Mark Suspect Areas

19 IVM Application Areas and Timeline Organ System In Vivo Microscopy Now 3 5 Years 7 10 years GI Clinical Procedures Standard of Care Standard of Care Cardiovascular Clinical Procedures Standard of Care Standard of Care Lung Clinical Trials Clinical Procedures Standard of Care Skin Clinical Procedures Clinical Procedures Standard of Care Breast Research Clinical Trials Clinical Procedures 2012 College of American Pathologists. All rights reserved. 21

20 Some Potential Case Use Scenarios In vivo - Real-time diagnosis in the endoscopy or interventional suite (pathologist present during the procedure) at remote site (images transmitted to a pathologist viewing workstation) - Regular signout pathologist views images off-line after procedure is performed Ex vivo Adequacy of needle biopsy Pathologist uses equipment and renders diagnosis in real time as intraoperative consult Pathologist uses equipment to guide tissue section sampling in grossing room

21 CPT Codes and Reimbursement CPT Esophageal Optical Endomicroscopy CPT Upper GI Optical Endomicroscopy - Both of these codes for upper GI procedures have been assigned to APC 419 for Hospital Outpatient Facility Reimbursement. Pathologist Interpretation CPT Optical Endomicroscopy Interpretation This code, intended for the pathologist, has been assigned to APC 0342 for Hospital Outpatient Facility Reimbursement. CPT 0291T, 0292T Intravascular OCT (carrier priced)

22 Getting Involved with IVM CAP Resource Guide CAP Atlas (coming soon) Multidisciplinary collaborations between pathologists and medical subspecialists - Contact local pathologists who are experts in reading microscopic images and can help set up and integrate these technologies into patient care work flow

23 CAP s Pathology IVM Resource Guide This guide was created to assist pathologists who are considering providing or developing in vivo microscopy skills and services within the next 24 months. The In Vivo Microscopy Resource Guide is free for members and is available via registration on the Member tab of College of American Pathologists. All rights reserved. 25

24 CAP s Pathology IVM Resource Guide Table of Contents Section 1 In Vivo Microscopy: The Basics 1.1 Background (5) 1.2 In Vivo Microscopy and Pathology (4) 1.3 Hot Topics: IVM in the News (2) Section 2 Understanding IVM Technology 2.1 In Vivo Microscopy Technologies (2) 2.2 Confocal Microscopy (4) 2.3 Optical Coherence Tomography (13) 2.4 Multiphoton Microscopy (5) 2.5 Optical Spectroscopy and Spectroscopic Imaging (3) Section 3 Insights from Early Adopters 3.1 Guillermo (Gary) J. Tearney 3.2 Maryann Fitzmaurice Section 4 Applications of Ex Vivo Microscopy (5) 4.1 Surgical Margins for Resection 4.2 Sentinel Lymph Nodes 4.3 Surgical Specimen Sampling 4.4 Virtual Histology 2012 College of American Pathologists. All rights reserved. 26

25 CAP s Pathology IVM Resource Guide Table of Contents Continued Section 5 Applications of In Vivo Microscopy 5.1 Gastrointestinal Tract (28) Pancreas/Biliary Other 5.2 Breast 5.3 Dermatology 5.4 Cardiovascular 5.5 Lung 5.6 Genitourinary 5.7 Gynecologic 5.8 Neurology 5.9 Eye Section 6 Current Standards of Validation Section 7 IVM Billing/Reimbursement 2012 College of American Pathologists. All rights reserved. 27

26 CAP s Pathology IVM Resource Guide Table of Contents Continued Section 8 Industry Education Resources 8.1 Industry Conferences 8.2 Biomedical Optics Education Resources Section 9 CAP In Vivo Microscopy Education Resources 9.1 Webinars Upcoming Webinars Archived IVM Webinars 9.2 CAP Annual Conference 9.3 Pathologists Speaking on IVM at Other Conferences Upcoming Conferences Prior conferences in CAP IVM Information Flyers Why IVM? Barrettes Other if more 9.5 IVM POET Report 2012 College of American Pathologists. All rights reserved. 28

27 Save the Date for These Upcoming FREE IVM Webinars or Listen to past Webinars Upcoming Webinars o Ex Vivo Date To Be Determined (November) o Richard M. Levenson, MD Archived Webinars o Chapter 7 from CAP ebook: New Paths...New Choices: Pathology in an Era of Advancing Science and Disruptive Health Economics Register for upcoming or the archived webinars by going to cap.org/webinars 2013 College of American Pathologists. All rights reserved. 29

28 Other CAP s Pathology Resource Guides The CAP has created the Pathology Resource Guides, a new tool to assist pathologists in understanding key emerging technologies. These Resource Guides are a new CAP member benefit available at no charge. Molecular Diagnostic (single gene, small panel) Genomic Analysis (large panels, exome, genome) Digital Pathology Register through the CAP member tab. You will receive periodic updates for two years. Questions? Contact capguides@cap.org College of American Pathologists. All rights reserved. 30

29 A CAP Tool- Short Presentations On Emerging Concepts (SPECs) Pathology SPECs are: o o o Prewritten PowerPoint presentation on emerging topics where molecular testing plays a key role in patient management. Designed for pathologists to customize and use for educating other physicians and health care leaders in their communities; e.g. tumor boards, grand rounds Focused on molecular tests that are actionable to patient care today. Now Available: New- Emerging Concepts in Molecular Testing in Breast Cancer Emerging Concepts in the Workup of Colorectal Cancer Emerging Concepts in Therapeutic Guidance for Metastatic Melanoma Emerging Concepts in the Diagnosis and Workup of Thyroid Cancer Emerging Concepts in Colorectal Cancer Hereditary Non-Polyposis Cancer (Lynch Syndrome) Emerging Concepts in the Workup of Polycythemia and Thrombocythemia: JAK2 To register, go to the CAP Member tab on cap.org. You do not need to be a member to utilize this free tool College of American Pathologists. All rights reserved. 31

30 CAPconnect is a professional community for CAP members. It offers: o Networking o Getting insights and feedback from peers o Accessing CAP resources o Keeping informed on professional issues o ** NOTE there is a discussion group on IVM! Join the community now by going to capconnect.cap.org and signing up! 2013 College of American Pathologists. All rights reserved. 32

31 2013 College of American Pathologists. All rights reserved.

32 THANK YOU! Thank you for attending our webinar IVM by Guillermo (Gary) Tearney, MD, PhD. For comments about this webinar or suggestions for upcoming webinars, please contact Jill Kaufman, PhD, Director of Personalized Health Care at NOTE: There is no CME/CE credit available for today s free webinar. 34