Download Imaging Requirements

Imaging Requirements
(RTOG 1106/ACRIN 6697)
Adam Opanowski, CNMT, PET, RT (N)
Imaging Analyst
ACR Core Laboratory
Imaging Requirements Training
Imaging Qualification and Quality Control
• Patients must be scanned on PET/CT scanners that have
been qualified by the ACRIN PET Core Lab
• A dedicated PET/CT scanner is mandatory
• A flat palette imaging couch is required
• Whenever possible, the same scanner should be used for
both the FDG-PET/CT and FMISO-PET/CT
– All patients will undergo FDG-PET/CT at baseline and RT planning and during RT for
treatment
– Baseline FMISO-PET/CT will be performed on a subset of patients
Imaging Requirements Training
Imaging Qualification and Quality Control
• Requirements for ACRIN PET
Qualification
– Uniform Phantom (water-filled
or Ge-68/Ga-68)
– Test Patient Images (base of
skull to mid-thigh)
– PET Qualification Application
Imaging Requirements Training
FDG-PET/CT
-
Patient Preparation
Injection of FDG
-
-
Decay Correction
Imaging Procedures
Imaging Requirements Training
FDG-PET/CT
Patient Preparation
• Prior to injection, patient must fast for at least 4 hrs.
• Encouraged to be well hydrated prior to scan
• Blood glucose measurement is required and must be <200
mg/dL
• Height and weight must be measured on the day of the
scan in the imaging dept. using calibrated and medically
approved devices (not verbally relayed by the patient)
Imaging Requirements Training
FDG-PET/CT
Injection of FDG
• IV catheter access line (18 or 20 gauge is preferred) is
placed in one arm (ideally contralateral [if accessible] to the
side of the primary tumor) for the FDG injection
• The dose of FDG will be 370 MBq (10-20 mCi) depending
on institutional procedure
• A saline flush of at least 10 mL should follow the injection
Imaging Requirements Training
FDG-PET/CT
Injection of FDG
• The exact time of calibration of the dose should be recorded using a
global time piece consistently used throughout the study for time
recording
• The exact time of injection should be noted and recorded to permit
correction of the administered dose for radioactive decay
• Any dose remaining in the tubing or syringe, or that was spilled
during injection, should be recorded
• The injection should be performed through an IV catheter and 3-way
stopcock
Imaging Requirements Training
Decay Correction
• A decay correction excel worksheet will
be provided to each site
• ACRIN website/Imaging Materials
• Used to ensure the net administered
activity entered into the scanner and
ITW is accurate
• Only the dose assay, time of assay, time
of injection, residual activity, and
residual time of assay can be entered –
all other cells are locked
Imaging Requirements Training
FDG-PET/CT
Imaging Procedure
All PET exams should contain 3 transaxial whole body series, attenuated and nonattenuated corrected PET and CT images
• Imaging must begin 60 +/- 10 minutes after injection (5070)
• The patient should empty his/her bladder immediately
before the acquisition of images
• The patient should be positioned on the flat table imaging
couch in treatment planning position
Imaging Requirements Training
FDG-PET/CT
Imaging Procedure
• The transmission scan should be a low-dose CT scan
without IV contrast for the PET/CT, done before the
emission scanning
– Oral contrast is permitted per institutional procedure
• The transmission scan type, length, etc., should exactly
match that used in the calibration and qualification
procedure
• An emission scan from skull base to thighs at 2-5 min per
bed position
Imaging Requirements Training
FMISO-PET/CT
-
Patient Preparation
Injection of FDG
-
-
Decay Correction
Imaging Procedures
Imaging Requirements Training
FMISO-PET/CT
Ordering Dose
• ACRIN notifies Cardinal
• Verification of activation/participation
• Cardinal will contact site to provide ordering information
• 72 hrs. notice to schedule a patient (availability)
• Generally, FMISO is available in the afternoon, but some
radiopharmacies can make product in the morning
– Dependent on production schedule
Imaging Requirements Training
FMISO-PET/CT
Patient Preparation
• The participant should not fast prior to injection of FMISO for this
study
• Encouraged to be well hydrated prior to scan
• Blood glucose is not required
• Height and weight must be measured on the day of the scan in the
imaging dept. using calibrated and medically approved devices (not
verbally relayed by the patient)
• Vital signs, including temperature, blood pressure, heart rate, and
respiratory rate, will be measured prior to injection of FMISO
Imaging Requirements Training
FMISO-PET/CT
Injection of FMISO
• IV catheter access line [18 or 20 gauge is preferred] is
placed in one arm [ideally contralateral to the side of the
primary tumor] for the FMISO injection
• The dose of FMISO must be 3.7 MBq/kg (0.1mCi/kg)
(maximum 260 MBq, 7mCi) in < 10 mL
• Minimize the length of IV tubing between the injection site
and the vein to avoid FMISO being left in the tubing
Imaging Requirements Training
FMISO-PET/CT
Injection of FMISO
•
The exact time of calibration of the dose should be recorded using a global time
piece consistently used throughout the study for time recording
•
The exact time of injection should be noted and recorded to permit correction of the
administered dose for radioactive decay
•
Any dose remaining in the tubing or syringe, or that was spilled during injection,
should be recorded
•
The injection should be performed through an IV catheter and 3-way stopcock
•
Adverse reactions – also referred to as adverse events [AEs] must be solicited in
open-ended fashion (i.e., “how are you feeling”)
Imaging Requirements Training
Decay Correction
• A decay correction excel worksheet will
be provided to each site
• ACRIN website/Imaging Materials
• Used to ensure the net administered
activity entered into the scanner and
ITW is accurate
• Only the dose assay, time of assay, time
of injection, residual activity, and
residual time of assay can be entered –
all other cells are locked
Imaging Requirements Training
FMISO-PET/CT
Injection of FMISO
Please Note:
•
AEs must be evaluated at each imaging session
•
AE monitoring will cover at least ten half-lives of the FMISO drug, or 24 hrs.
•
AEs for FMISO are defined as any signs of illness or symptoms that have appeared
or worsened since the infusion of the FMISO
•
Participants must be queried for potential AEs at the following time points:
– At the time of injection
– Before leaving the PET suite
– If they call the site as instructed for any concerns during the 24 hours after FMISO
administration
– By telephone up to 24 hrs. post-FMISO injection
Imaging Requirements Training
FMISO-PET/CT
Imaging Procedure
All PET exams should contain 3 transaxial whole body series, attenuated and nonattenuated corrected PET and CT images
• Imaging of the chest (from apices to the base) will occur 2
hours +/- 10 minutes post injection (110-130)
• The patient should empty his/her bladder immediately
before the acquisition of images
• The patient should be positioned on the flat table imaging
couch in treatment planning position
Imaging Requirements Training
FMISO-PET/CT
Imaging Procedure
• The transmission scan should be a low-dose CT scan (120 – 140
kVp, 80 effective mAs) without contrast for the PET/CT and done
before the emission imaging
• A 20-30 minute emission scan of the chest is performed focusing on
the area of the primary tumor, with the left ventricle or aorta included
in the FOV to be able to measure blood activity
• There should be at least 10 minutes per axial of view. If greater than
3 axial fields of view are required to cover the lungs, a portion of the
lungs may be excluded as far from the primary tumor as possible
Imaging Requirements Training
FMISO-PET/CT
Imaging Procedure
• The blood values for the scans will be derived from a region
of interest in a major vessel or cardiac chamber within the
FOV
• Vital signs, including temperature, blood pressure, heart
rate, and respiratory rate, are measured again at
completion of the FMISO-PET/CT, and PRN (as needed)
throughout the procedure
Imaging Requirements Training
FMISO-PET/CT (Vital Signs)
Monitoring for Physiologic Effects of FMISO
•
Section 6.13 of protocol
•
Vital signs will be assessed both before and
after injection of FMISO
•
•
•
•
•
Imaging Requirements Training
Time vital signs were measured
Pulse
Systolic and Diastolic BP
Respiration
Patient temperature
FMISO-PET/CT (AE)
Imaging Requirements Training
Imaging Forms
• FDG-PET/CT
– (TA) PET/CT Technical Assessment Form
– (EX) Dose Administration Treatment Exposure Form
– (TD) FDG-PET/CT Imaging-Related Drug History
• FMISO-PET/CT
– (TA) PET/CT Technical Assessment Form
– (EX) Dose Administration Treatment Exposure Form
– (SA) Safety Assessment Form
Imaging Requirements Training
Imaging Forms
• It is recommended that each form is available for the
Imaging Technologists on the day of the scan to be
completed by the Technologist
• The Forms can be submitted through the ACRIN data
center (www.acrin.org)
• The forms can be found on the ACRIN website:
http://www.acrin.org/PROTOCOLSUMMARYTABLE/Protoc
ol6697/6697DataForms.aspx
Imaging Requirements Training
Image Submission
• All imaging data should be transferred within 24 hrs.
following the imaging session
• TRIAD
– ACRIN can provide software for installation on a PC at
your site that collects, anonymizes, and submits image
sets from your PET/CT system or from your PACS
• CD/DVD
– If needed, sites can submit imaging CD-ROM, the mode
of shipment should include package tracking
Imaging Requirements Training
Image Transmittal Worksheet (ITW)
• A completed, signed Image Transmittal Worksheet
(ITW) MUST accompany all imaging exams submitted
to ACRIN for each time point.
• The ITW can be found on the ACRIN website under
Protocol Summary Table at:
http://www.acr.org/6697_protocol.aspx
• For exams submitted via Triad, complete the ITW and
fax to 215-923-1737 or email to [email protected]
Imaging Requirements Training
Image Transmittal Worksheet (ITW)
• Ensure ITW is fully and
accurately completed
• If images are submitted via
Triad, fax or email ITW after
submission is complete
• If images are sent via CD/DVD,
the ITW must accompany the
disk
Imaging Requirements Training
Quality Control and Query Process
• Core lab Imaging Technologist:
– Will perform image quality control (QC)
– If data discrepancies are identified during image Quality Control
review, Imaging Technologist will issue a query
– Imaging queries will be emailed to appropriate site personnel
– Queries should be resolved within five (5) business days
– Submit query forms via fax or email
• Fax: 215-923-1737
• Email: [email protected]
Imaging Requirements Training
Imaging QC Issues Examples
• Missing or incomplete submission (image data and/or ITW)
• Corrupt media/unable to open images
• Discrepancy between ITW and DICOM header (e.g.,
weight, dose information)
• Data entry and/or calculation error on ITW
Imaging Requirements Training
Thank you
Support Materials can be found on the ACRIN website
- Site Imaging Manual
- Imaging Requirements slides
Adam Opanowski, CNMT, PET, RT (N)
215-940-8890
[email protected]
Imaging Requirements Training