Goals for Lecture Challenges of Introducing New Technologies into the Clinic

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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
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