Goals for Lecture Challenges of Introducing New Technologies into the Clinic Eric E. Klein, Ph.D. Lakshmi Santanam, Ph.D. Washington University St. Louis MO Introduction: Staffing Implementing new technologies into the clinic is challenging on many levels. Besides obvious manpower issues, physicists are challenged with; unreasonable timelines driven by market competition, technical staff acceptance, incompatibilities of devices provided by multiple vendors lack of opportunities for proper education. Vendors have capitalized on the open purse-strings hospitals provide due to the healthy reimbursement for IMRT and IGRT (daily localization). Methods to Estimate Manpower Needs How to Formulate Implementation Timelines and Tasks Learn from Our Experiences, Good and Bad - Workarounds Staffing Levels Physicist must use tools such as the Abt studies to negotiate proper staffing before the technologies arrive. This includes defining roles of all personnel involved (IT, Therapist, Dosimetrist, QA Personnel, etc.) 1 A Grid for Justifying Clinical Staffing Budgets When a physicist negotiates staffing requests to administration, she/he often refers to the “blue book” (ACR), and resources such as Abt studies. This is often met with questions as to how to derive the time it takes to perform tasks properly, and what level of experience is required. The result is often insufficient and/or inexperienced staff handling complex and cumbersome tasks. We undertook development of a staffing justification grid to equate the clinical needs to the quantity and quality of staffing required. Results: Tasks and Faculty are assigned according to needs and qualifications XRT: Conventional 2D/3D Imaging TP: CT Simulation, PET,MR Imaging Rx: Daily Localization Devices CPA (Clinical Physics Assistants) Task/Person Assoc Assoc Assoc Assoc Assist Instruct Assist Instruct Assoc Instruct Instruct Instruct CPAs** Total XRT 0.1 0.05 0.05 0.05 0.05 0.05 0.05 0.2 0.1 0.25 0.3 0.5 1.75 Brachy 0.4 0.1 0.2 0.1 0.15 0.3 0.2 0.3 0.25 2 QA 0.05 0.05 0 0.1 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.6 Specials (TBI, 0.05 0.1 0.05 0.05 0.25 ESBT) Imaging TP 0.2 0.05 0.15 0.4 Imaging Rx 0.05 0.1 0.15 0.15 0.1 0.55 IMRT 0.2 0.25 0.3 0.1 0.25 0.35 0.2 0.15 0.05 0.1 0.1 0.15 0.35 2.55 Teaching 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.5 Administ.* 0.2 0.5* 0.7 IT Support 0.5 0.5 Development 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 2.2 Grant Effort Vacation Gamma 0.1 0.1 0.25 0.1 0.2 0.75 VA 0.15 0.2 0.15 0.5 1 1 1 1 1 1 1 1 0.55 1 1 1 1.7 13.25 Methods First used Abt study to derive time per task X the anticipated number of such tasks. Inclusion of vacation, meeting, and developmental time is incorporated along with allocated time for education and administration. Mapping the tasks to the level of competency & experience needed. Non-staff personal, such as IMRT QA technicians or clerical staff are included. This grid method equates clinical needs with the quantity of staffing, and generates the personnel budget. IMRT Patient activities (77301, 77418) Average of 600 patients per year based on trend of 12 new starts per week. On average, 9 hours per patient is spent. (Abt study estimates 12.6 hours per patient). This effort totals 5400 hours annually. 2 EXTERNAL BEAM SERVICES Based on 1400 conventional patients per year, the following hours are spent to accomplish the tasks Time per # of Events Total Time Task Task (hrs) per year Per Year (Hours) Chart Review 0.20 1400 x 5 (weeks per 1,400 patient) = 7,500 BDC check 0.10 4410 441 2D plan consult and check 0.4 560 224 3D plan check and check 1.0 339 339 In-vivo dosimetry 0.01 6300 63 Special Medical Physics Consultation 2.5 140 350 (for Non-Special Procedures) Special Dosimetric 1.00 50 50 Measurements Total Hours 2867 Unscheduled consultations.: This effort totals 625 hours annually. Construction and/or verification of special bolus/immobilization devices. This effort totals 80 hours annually. Total FTE for XRT = 1.75 Inexperienced Instructor Task XRT Brachy QA Specials (TBI, ESBT) Imaging TP Imaging Rx IMRT Teaching Administration IT Support Development Grant Effort Vacation Gamma VA Total FTE 0.2 0.05 0.05 0.1 0.15 0.05 0.2 0.2 1 Experienced Associate Professor Task XRT Brachy QA Specials (TBI, ESBT) Imaging TP Imaging Rx IMRT Teaching Administration IT Support Development Grant Effort Vacation Gamma VA Total FTE 0.05 0.1 0 0.2 0.3 0.05 0.2 0.1 1 Results: Tasks and Faculty are assigned according to needs and qualifications XRT: Conventional 2D/3D Imaging TP: CT Simulation, PET,MR Imaging Rx: Daily Localization Devices CPA (Clinical Physics Assistants) Task/Person Assoc Assoc Assoc Assoc Assist Instruct Assist Instruct Assoc Instruct Instruct Instruct CPAs** Total XRT 0.1 0.05 0.05 0.05 0.05 0.05 0.05 0.2 0.1 0.25 0.3 0.5 1.75 Brachy 0.4 0.1 0.2 0.1 0.15 0.3 0.2 0.3 0.25 2 QA 0.05 0.05 0 0.1 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.6 Specials (TBI, 0.05 0.1 0.05 0.05 0.25 ESBT) Imaging TP 0.2 0.05 0.15 0.4 Imaging Rx 0.05 0.1 0.15 0.15 0.1 0.55 IMRT 0.2 0.25 0.3 0.1 0.25 0.35 0.2 0.15 0.05 0.1 0.1 0.15 0.35 2.55 Teaching 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.5 Administ.* 0.2 0.5* 0.7 IT Support 0.5 0.5 Development 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 2.2 Grant Effort Vacation Gamma 0.1 0.1 0.25 0.1 0.2 0.75 VA 0.15 0.2 0.15 0.5 1 1 1 1 1 1 1 1 0.55 1 1 1 1.7 13.25 3 Conclusion from Grid Tool Though our grid is for a large academic facility, the methodology can be extended to a nonacademic setting, and to a smaller scale. The grid is easily adaptable when changes to the clinical environment change, such as an increase in IMRT or IGRT applications. Trilogy: Equipment - Requested Routine QA Trilogy: Daily Output/Energy/Flatness/Symmetry Check Device Cardinal Health: 7600 Double Check Pro (switching for all linacs over time) $6,500 In-vivo Dosimetry: Sun Nuclear Electrometer and 3 diodes (wireless system) $6,660 IMRT QA Commissioning Phantom for Plan Validation (including heterogeneity corrections): Med-Tec: Benchmark IMRT QA Phantom $9,950 Additional Patient QA Phantom: Constructed by WUSM $3,000 Additional micro-chambers for Patient QA: CNMC Co.: N3103 micro-chambers 2 x $1,250 = $2,500 Trilogy: Equipment - Ordered Trilogy: Equipment - Requested Routine QA Trilogy: Daily Output/Energy/Flatness/Symmetry Check Device Cardinal Health: 7600 Double Check Pro (switching for all linacs over time) $6,969.10 (quote attached) Imaging Validation and Quality Assurance Digital Reconstructed Radiograph Phantom: Modus Medical Devices: Quasar Beam Geometry Phantom $9,500 Scandatronix-Wellhoffer: Water reservoir and license for OmniPro to ADAC: $7,227 (request submitted August) High Precision Anthropomorphic Imaging Phantom: The Phantom Laboratory: Customized Chest Phantom SK200 $30,000 IMRT QA Scandatronix-Wellhoffer I’mRT Phantom: $9,150 (quote attached) Dual Input Electrometer and additional micro-chambers for Patient IMRT QA: CNMC Co.: N3103 micro-chambers $8,865 (quote attached) 4 Trilogy: Equipment - Ordered Imaging Validation and Quality Assurance High Precision Anthropomorphic Imaging Phantoms: The Phantom Laboratory: Customized Chest Phantom SK200 + Pelvis Phantom SK250 + Upgrade of CatPhan 500 to a CatPhan 504: $10,452 +shipping (request submitted August) Important to know what exact equipment is coming with the machine! Implementation Plan Physicists must be the key decision makers in choosing a team of technical staff personal to be the initial implementers. We have found the initiation of a new technology is smoothest if the dosimetrists and therapists first involved are pro-active and capable of implementing a new technology. Procedure writing should be a team effort to ensure there is ownership. Timelines Physicists should set realistic timelines that depend on the agreed on staffing levels including IT assistance, and on compatibility of all systems involved. Washington University implementations in recent years, include; MLC-IMRT, Tomotherapy, OBI and CBCT Video surface imaging, Gating, US localization, etc. Implementation Plan: Lecture Give Lectures Before Technology Arrives Great Way to Identify Pro-active Team Members Vendor Provides canned talks Borrow Slides from Colleagues 5 Implementation Plan: Site Visit Visit Facility that has SAME Arrangement as You Do. (EMR, TP, ~ size) Vendors Love to Send you to Their Showcase Facilities. Waste of Time Bring Key Personnel (Therapist, etc.) Take Pictures Commissioning example: Testing AlignRT ALIGN-RT image taken after a known shift (3, 3, 2) was applied to the couch. Validated Shifts Implementation Plan: Trilogy Acceptance Testing completed on 9/27/2005 Commissioning 90% complete. Still need to validate IMRT (match to other machines) IMPAC 8.3 (needed for Trilogy) installed in department from 10/28-10/30. IMPAC 8.3 connection to Trilogy on 10/31. IMPAC remains for training! Varian training for 4D Workstation on 11/01 Testing to ensure plan transfer from Eclipse to Trilogy via IMPAC and treatment on Trilogy (4D WS) on 10/31 and 11/01. IX (Machine operation) incl. IMRT targeted start date of 11/02. Initially transfer of existing patients from Treat 8 and/or 9 to Trilogy, working on schedule from 7AM-12PM through end of November. Afternoon time is still needed for testing and training. OBI is tested and ready for implementation. On-site training scheduled for 11/29-30. Target start date of Dec. 1st. Commissioning example: Testing AlignRT Post ALIGNRT image after the shifts were applied to the couch to bring the phantom back to the isocenter. Validated Central Position 6 Protocols Protocols: OBI – Questions asked • As daily localization empowers therapists to make decisions on shifting patients, physicists should work with clinicians to decide • What is the minimum shift required for a shift to take place, • When is the shift too much, • Whether re-evaluation is required. Protocols: OBI – Make Case for Shift/No Shift Site Pelvis 1 Mean (cm) Long/Lat/Vert -0.47 0.02 -0.191 Pelvis 1 0.39 0.2 0.34 H&N -0.1 0.13 -0.01 Brain 0.018 -0.12 -0.08 Tolerance for applying shifts: Shifts in one direction: 2mm Shifts in 2 directions: total > 3 mm ?? Periodicity of KV/MV imaging based on sites? Weekly, daily, twice a week? Re-imaging – before and after shifts? Aligning patients near the isocenter: Compare the TXSU (with target contours) to confirm alignment Rotations vs Translations: ( Compare the DRR vs Portal Image) Confirm electronic crosshair accuracy: Compare the printout from TPS with the DRR in IMPAQ before the first treatment. Protocols: OBI – Make Case for Shift/No Shift Site Prostate 1 Mean (cm) Long/Lat/Vert -0.7 -0.15 -0.16 Prostate 2 0.23 0.25 -0.1 Prostate 3 -0.01 -0.22 0.21 7 Protocols: AlignRT: PBI Target Localization Study Alignment lasers positions patient with respect to skin marks. Couch coordinates recorded manually by the therapists. Orthogonal X-rays films acquired. Therapist uses 2D match software to determine projected couch offsets. Couch not moved. Align RT acquires digital representations of patient surface topography. Therapist uses Align RT to determine projected offsets. Couch moved to projected reference position according to Align RT. Final couch coordinates recorded manually by therapist. Therapist acquires additional Align RT image to confirm the positional error is below accepted error threshold. Orthogonal X-rays films will be acquired. The films will be used for post-procedure analysis. The couch will not be moved. The patient will receive treatment. Data Transfer at Barnes-Jewish Hospital / Washington University Brilliance Big Bore Pinnacle3 IMPAC Varian Trilogy Brilliance 64 WORKAROUNDS The Necessary Evil Commissioning example: CBCT Testing the Kilovoltage source and Imager for CBCT capability Testing integrity of data transfer between Eclipse and ADAC treatment planning system and OBI through IMPAC Validating the 3D- 3D Match software on the OBI workstation Head and Neck site Pelvis site Thorax site Wrong site match test Using ALIGNRT software Determination of CBCT dose using CTDI phantom RPM CT Scanner RPM Trilogy 8 Commissioning example: CBCT Testing integrity of data transfer between Eclipse and Pinnacle treatment planning systems for OBI through MOSAIC Commissioning example: Understanding Different Coordinate Systems The Philips CT Co-ordinate system The DICOM Co-ordinate system -z z x x z y y The Eclipse Co-ordinate system The Pinnacle Co-ordinate system z -z y x x y Commissioning example: Testing Transfer between Different Coordinate Systems Use of DICOMTree to xfer Coordinates (Site Setup) for CBCT for MOSAIC (V 0.83) •Transfer of the co-ordinates from CT to the TPS is already established •Need to decipher the transfer from the planning systems to MOSAIC •DICOM co-ordinate system is the key •DICOM viewer named DCMTREE was used to view the isocenter co-ordinates( x, y, z) of the treatment planning CT •These co-ordinates were manually transferred with a unit conversion (mm to cm) into MOSAIC 9 Commissioning example: Testing Transfer between Different Coordinate Systems To test this hypothesis, a phantom was setup to the isocenter, by aligning the lasers to the wires on the phantom. The isocenter co-ordinates were read in the DCMTREE and input into MOSAIC. This isocenter read x = 0, y = 5.2, z = 0.3 in IMPAC and the 3D match software yielded an exact match. Workaround for Contours TPS(PINNACLE ) TPS(PINNACLE ) OBI CT data and contour transfer 4DTC OBI CT data and contour transfer TPS( Eclipse) 4DTC MOSAIC(1.2) Temporary Workaround MOSAIC(1.2) Initial Situation Commissioning example: Testing Transfer between Different Coordinate Systems Eclipse TPS (cm) DCMTREE (mm) IMPAC (cm) SETUP (cm) 3D-3D MATCH(cm) 0, 0.3, -5.2 0, 52. 49,3 0, 5.2, 3 0, 0, 0 0, 3.5, 0 0, 0, -1.0 0, 0, 0 0, -3.6, 0 0, 0, 1.1 Validated Long Shift Fluoroscopic Verification Target positioning viewed with kV fluoroscopy Tumor itself Implants – (seeds, clips, stents) stents) Extremely useful and currently the best verification for individual patient QA With Varis/Aria Varis/Aria – port outline With IMPAC – no outline 10 Our Solution( Hubie) TPS(PINNACLE) OBI( GATED KV) 4DTC CT data and contour transfer Hubie ( Wiring of PTV) TPS(PINNACLE) OBI( GATED KV) 4DTC MOSAIC(1.2) Better Temporary Workaround CT data and contour transfer TPS( Eclipse) ( Field Aperture contour) Our Solution – Hubie* Scaling/Alignment markers DRR printed on paper Target and referenced marks outlined with wire DRR taped to the portal imager Wire outline shows in acquired port films MOSAIC(1.2) Temporary Workaround Wire Outline of object to be tracked *James Hubenschmidt Hubie Diagram Hubie – Taped on Portal Imager 11 Setup Verification Using Hubie for Abdomen Develop QA Program OBI – Daily Daily OBI Quality Assurance for Trilogy_1 (Varian IX SN 1062) Department of Radiation Oncology, Barnes-Jewish Hospital, WUSM Date:________________________ Initials:______________________ Position Verification: EPID at P5 Expected Observed Difference Tolerance P5 Pendant Readout -50.1,0.00,0.00 ___, ___, ___ ± 0.1 mm ODI on EPID 146.5 cm ______ cm _____mm ± 2.0 mm EPID centering lasers vs. marks OBI – Daily QA Position Verification of kV Source Detector Place Locking Bar-Cube over open window (position F2) line up lateral etchings to lasers, line up AP etchings to cross-hair Call up “IMRT QA” Patient Deploy Imaging Arms Perform Tube Warm-UP Fluoro lateral image using “ABC” Take AP-MV and Lat-kV image and record graticle isocenter to center “bb distance Rotate 90° and repeat for Lat-MV and AP-kV Observed Difference Tolerance Satisfactory? Image Centering Test AP-MV _____mm ± 2.0 mm Yes No Lat-kV _____mm ± 2.0 mm Yes No Lat-MV _____mm ± 2.0 mm Yes No AP-kV _____mm ± 2.0 mm Yes No If any are Unsatisfactory, page physics _____mm ± 2.0 mm Satisfactory? Yes No Yes No Yes No OBI – Daily QA: 2D-2D match accuracy Setup the phantom to the off-set marks. The couch co-ordinates should read the following. VRT: 110.3 LNG: 150.3 LAT: 102.6 Fluoro lateral image using “ABC” Take an AP and Lat image and perform 2D/2D match. Note shifts suggested by 2D/2D software. Apply shifts. Go in the room and check if the cube is centered to the lasers on the cross-hairs. Expected(cm) Measured(cm) Expected- Tolerance Measured (< 2mm) Vrt -1.0 Lng 1.0 Lat 1.0 12 Timeline Example for Protons UFPTI PTS Validation and Commissioning Plan The commissioning of the PT system is subdivided in the following parts: 1. Safety: Indicators, interlocks, surveys (x-ray tubes, neutron exposure, activation) 2. Alignment: Mechanical components, X-ray image guidance system 3. Dosimetry: Absolute calibrations, monitor chambers, relative dosimetry, test of ConvAlgo parameters 4. Treatment Planning: Eclipse required measurements, AP/RC, inhomogeneities Pre-Commissioning Estimate of Time Requirement Type of measurements beam Pre-liminary measurements Dose distribution 11 0.3 5 0.1 303 7.6 13 0.3 22 0.5 2 0.1 Commissioning Eclipse 14 0.4 116 2.9 Alignment validation 20 0.5 0 0.0 Safety validation 4 0.1 0 0.0 System Integration and Process Validation 16 0.4 40 1.0 Training sessions 40 1.0 20 0.5 Mock treatments 88 2.2 0 0.0 Total 7. Documentation and procedure development. Thanks to Zuofeng Li, UoF Analysis Total & Treatment Planning Total duration duration [weeks] [h] measurements Radiation protection measurements 5. System Integration: Eclipse => MOSAIQ => PTS, AP/RC fabrication and fitting, DIPS correction application, etc 6. Training and Mock Treatments: Establish clinical flow. & Tests Measurements Total Total duration duration [weeks] [h] 517 hours 196 hours 74 7+2 hour shifts one-shift-a-day days 24 24 8+2 hour shifts one-shift-a-day days 4.9 five-days-aweek weeks 74 Total commissioning duration 14.8 five-days-aweek weeks 14.8 weeks projected start date 4/24/06 projected finish date 8/5/06 actual start date 4/24/06 actual treatment state date 8/14/06 Weekly Updates of Scheduled vs Completed Activities For our Incoming Proton Machine (SRS Clinatron 250) Administration has allocated 3 months for AT & Comm – We expect 6-8 months Commissioning Progress Scheduled Completed 55 45 Days 35 25 15 5 23-Apr -5 30-Apr 7-May 14-May 21-May 28-May 4-Jun 11-Jun 18-Jun 25-Jun 2-Jul 9-Jul Date 13 Education and Training Ongoing continuing education and scheduled migration of other support staff to operating the new technology should be the responsibility of the physicist in charge of the device or technique. This includes re-education of all involved for new software releases or new processes. And finally, physicists should ensure they receive proper training beyond what the vendor provides. This may be in the form of legitimate courses and workshops, or visits to institutions using the new technology similar to your clinical setup (the best). Education and Training Per Varian: Education, Technical Expertise and Preparation We require customers to have at least 4 weeks of hands-on use of these products before OBI training. VarisVision 65/70 4DTC Eclipse (in most cases) The site should complete the necessary configuration in Vision Administration and Treatment Administration before on-site training. The site should create the plans that will be needed for training. We will provide CT scans of the marker block and respiratory gating phantoms, along with a summary of the plans to be created and moved to treatment. The site should CT scan an anthropomorphic phantom, create plans and move to treatment for use during training. Plans do not need to be elaborate. We will make suggestions. The phantom must be available during training. Patients should not be scheduled on the linac during OBI training. OBI cannot be trained on live patients. But, we don’t have Varis/Vision…………. Education and Training Varian’ Varian’s Barnes Jewish –Siteman Cancer Center OBI TRAINING Schedule November 29-30, 2005 Physics/Dosimetry should scan an anthropomorphic phantom, create plans with Set-up Fields and DRR’s in Eclipse or 3rd party TPS. Move plans to treatment and complete scheduling so they are available for use in training. Configuration of Vision Administration, Linac, and Treatment Administration, as covered in the OBI course, should occur before the on site follow-up visit. Verify configuration of the OBI DB Daemon. (ECLIPSE TREATMENT PLANNING/Varis Vision Record and Verify USERS ONLY) But, we don’t have Varis/Vision…………. Global Training Issues The physics and radiotherapy community should address how: New physicists (Residencies), Dosimetrists (MDCB), and Therapists (testing out) are being trained and evaluated, and How experienced personal are being re-trained for our new environments. 14 Do and Don’t Do Ensure Staffing (Physics, IT, etc.) is adequate Ensure you have Adequate Equipment Budget Pick Key, Pro-active Team (Therapist) Agree on Timelines that are Realistic and will Slide if there are Delays or Lack of Proper Data Transfer Methods Track Progress and Document Meetings Site Visit a Facility that has the SAME setup Ensure there is an Education Plan Beyond What the Vendor Provides Do and Don’t Don’t …Be Told “You Will Squeeze the Implementation In” …Make Due with Existing or Borrowed Equipment …Accept Team Members Who “Are Do an Opportunity” …Agree on Timelines that are Short and/or Date Restrictive …Visit an Incompatible Facility that the Vendor has Chosen …Limit Training to What the Vendor Provides 15