IMAGE MANAGEMENT PLAN FOR ACRIN PA 4003 Evaluation of the Ability of a Novel [ 18 F] amyloid ligand ([ 18 F-AV-45]) to distinguish patients with a

Transcription

1 IMAGE MANAGEMENT PLAN FOR ACRIN PA 4003 Evaluation of the Ability of a Novel [ 18 F] amyloid ligand ([ 18 F-AV-45]) to distinguish patients with a clinical diagnosis of Alzheimer s disease from cognitively normal elderly individuals 1

2 Table of Contents Letter of Introduction and ACRIN contacts... 3 Imaging Site Responsibilities... 4 Preparing Subject for [ 11 C]-PIB PET scan... 5 [ 11 C]-PIB PET scan Acquisition... 6 File Naming Procedures... 9 Brief Overview of Image QC... 9 Query Process...10 Head Positioning and Restraint... 3 ACRIN Image Transmittal Worksheet (ITW) to include PET and MRI...14 PET Technical Assessment Form (TA)...15 Dear Imaging Site, 2

3 This Image Management Plan (IMP) contains the technical instructions and guidelines on how to acquire the [ 11 C]-PIB PET images for the ACRIN PA 4003 study entitled: Evaluation of the Ability of a Novel [ 18 F] amyloid ligand ([ 18 F-AV-45]) to distinguish patients with a clinical diagnosis of Alzheimer s disease from cognitively normal elderly individuals. You will be required to acquire the PET images according to the imaging protocol within this document. These images must be then transmitted to the facility at ACRIN. Any issues noted will be relayed to the imaging site accordingly for resolution. There are mandatory forms that need to be filled out at the time of each [ 11 C]- PIB PET scan acquisition and submission. Thank you in advance for your diligent effort in adhering to these procedures and for helping us ensure that the integrity of the image data collected for study ACRIN PA 4003 is compliant. We look forward to collaborating with you! ACRIN Core Lab Adam Opanowski (215) Dena Flamini (215) aopanowski@phila.acr.org dflamini@phila.acr.org Imaging Site Responsibilities 3

4 As part of the ACRIN PA 4003 study, the imaging site will perform [ 11 C]-PIB PET scans, as well as MRI scans of the brain. The image data will be submitted to ACRIN directly. ACRIN will then transfer the images to a 3 rd party core lab. Perform daily Camera QA Adhere to Proper Subject Positioning Image Acquisition [ 11 C]-PIB PET Scan according to guidelines within this document and protocol Image Reconstruction and Processing according to guidelines within this document and protocol Submission of PET Technical Assessment Form (TA) along with images to ACRIN Submission of Image Transmittal Worksheet (ITW) along with images to ACRIN Prompt response to queries issued by ACRIN Daily Camera Daily quality assurance is to ensure scanner/ancillary equipment stability and quality throughout the project. Dedicated PET scanner: PET scanner should have an up to date calibration, normalization and a cross calibration with dose calibrator on the date of each imaging session. A daily QC/blank scan (empty port transmission) scan should be done at the beginning of the day the scanning is to be completed. The QC sinogram should be visually inspected for abnormalities. If there is a possibility that the abnormality could impact the quality of the PET scan the study should be rescheduled. PET/CT Scanner: 4

5 The PET scanner should have an up to date calibration and normalization on the date of the imaging session. The CT scanner will have up to date daily, monthly, and annual tests for spatial resolution, contrast resolution, noise, slice width, kvp waveform, average CT number of H 2 O, standard deviation of H 2 O, radiation scatter and leakage done per their SOP and documented. A daily QC check should be done at the beginning of the day the scanning is to be completed. This scan should be visually inspected for abnormalities. If there is a possibility that the abnormality could impact the quality of the PET scan the study should be rescheduled. Ancillary Equipment: Quality control of the dose calibrator should be performed throughout the course of the study. This typically will include daily constancy, quarterly linearity and annual accuracy tests. These will be documented. Preparing Subject for [ 11 C]-PIB PET scan and Positioning Remind your subjects that fasting is not necessary for an [ 11 C]-PIB PET scan. Proper subject positioning is a key aspect of the successful completion of the PET exam. It is important to take the time necessary to ensure not only that the patient is properly positioned but can comfortably maintain that position throughout the duration of the scanning session. Have the subject remove any bulky items from their pockets such as billfolds, keys, etc. In addition, they should remove eyeglasses, earrings, hair clips/combs if present. If possible they should try and remove hearing aids also. Position the subject so that their head/neck is relaxed. It may be necessary to add additional pads beneath the neck to provide sufficient support. Use the lasers to ensure there is little or no rotation in either plane. 5

6 The head should be positioned so that the imaginary line between the external canthus of the eye and the external auditory meatus is vertical Use support devices under the back and/or legs to help decrease the strain on these regions. This also will assist in the stabilization against subject motion. Once the subject has been positioned, foam pads can be placed alongside the head for additional support. Velcro straps and/or tape should also be used to secure the head position. Vacuum bean bags/sheets can also be used in this process. If using a dedicated PET system, it is helpful to perform a short emission scan to check for all of the brain s anatomy in FOV. The patients should be offered a panic button or be reassured that someone is watching or able to hear them at all times. [ 11 C]-PIB PET Scan Acquisition Protocol Please adhere to the following image acquisition protocol for acquiring, reconstructing and transmitting images to ACRIN. [ 11 C]PIB PET Imaging Protocol Approximately 40 minutes following the bolus intravenous injection (administered over seconds) of mci of [ 11 C]PIB, subjects will be placed in the PET scanner, positioned so that the entire brain is in the field of view. The PIB PET scans will be acquired in dynamic, 3-D imaging mode for 20 minutes (4 x 5 minute frames) beginning 50 minutes after injection of [ 11 C]PIB. No vital sign assessment will be performed for the PIB PET study. Subjects will receive 5 10 minute transmission scans following each PET scan. The subject will be removed from the PET scanner, and allowed to rest prior to the injection of the second experimental ligand. A minimum of 120 minutes must elapsed between the injection of [ 11 C]PIB and the start of the second ligand image acquisition (i.e., 6 half-lives of [ 11 C]PIB). A schematic indicating the PET scanning sequences is shown below and is intended to be flexible enough to be sensitive to subject comfort but allow for complete data acquisition from subjects who wish to complete the full protocol on the same day. 6

7 PET imaging protocol for [ 11 C]PIB and [ 18 F]-AV-45 IV line placements Subject positioned in scanner 1 st Transmission scan AV-45 Injection Subject repositioned in scanner at Begin 10 AV-45 Scan Check 10 Scan and Repeat if Necessary [ 11 C]PIB + [ 18 F]AV-45 Protocol 50 PIB Uptake 20 PIB Scan 50 AV-45 Uptake AV-45 Scan PIB Injection Study break: subject removed from scanner 2 nd Transmission scan Time (min) Begin 20 PIB Scan

8 [ 11 C]-PIB PET Scan Reconstruction Protocol Do Retro Reconstruction as follows (Transmission scan): CPU based / Segmentation Method: Backprojection Image Size: 128 Image Zoom: 1.0 Brain mode: ON Offset cm: X=0.0 Y=0.0 Filter: Gaussian Kernel FWHM (mm) = 9.0 Axial Filtering: ON Scatter Correction: ON Do RetroReconstruction as follows (Emission scan) CPU based Method: Iterative Iterations: 4 Subsets: 16 Image Size: 128 Image Zoom: 2.5 Brain mode: ON Offset cm: X=0.0 Y=0.0 Filter: Ramp Kernel FWHM (mm) = 5.0 Axial Filtering: OFF Scatter Correction: ON 8

9 PET Scanners Acquire an attenuation correction scan using rod sources for 7 minutes to 10 minutes, all depending on the strength of the rod sources during time of study. Transmission scan can be performed either prior to or post emission scan. Apply segmentation and re-projection routines for attenuation correction. PET/CT Scanners Use standard CT acquisition parameters for attenuation correction All imaging data must be sent to ACRIN via disc or sftp (TRIAD software) immediately following the scan. Any deviations from the [ 11 C]-PIB imaging protocol must be reported to ACRIN on the PR (protocol deviation) form. The imaging site is expected to document the deviation, the reason for it, any resolution/ corrective action, if any, on the Protocol Deviation Form. Imaging data to be submitted 1. CT, if used for attenuation correction (AC). 2. Screening MRI (or in CT when MRI is contra-indicated). 3. PET, attenuation corrected reconstructed data. 4. A completed Image Transmittal Worksheet must be submitted. Image Transmittal Worksheet (ITW). Attachment D Brief Overview of Image QC by ACRIN and 3 rd party core-lab In study ACRIN PA 4003, all of the images, which include MRI, CT and PET images, will be reviewed for technical accuracy/completeness by ACRIN prior to the independent analysis performed solely by the 3 rd party core lab. An initial QC check and review of image data will occur after the first subject is imaged at the site in this study. Any major issues with the images will be promptly communicated to the imaging site before the error may be inadvertently repeated on subsequent patients. Hence it is important that sites submit images immediately. 9

10 ACRIN will review [ 11 C]-PIB imaging data for the following: Adherence to Imaging Protocol as noted in the protocol and this manual Ability to display the imaging data Appropriate header information and anonymization Reconcile the Technical Assessment Form with imaging data Evaluate the technical image quality (i.e. motion, artifacts) Assess suitability for quantitative analysis For those deviations noted, ACRIN will query the site for clarification and discuss a plan of action. Query Process - for Missing, Incomplete or Incorrect Information 1. If any imaging data are found to be missing, inaccurate or inconsistent with the imaging protocol, a Z5 query form will be completed, and ed to the study coordinator. 2. All queries will be followed until resolution. 3. The site must maintain a hard copy of the completed query form at the site. 4. Subject data involving queries that are still unresolved at the close of the study and/ or prior to the independent read will be documented as such. Image Data Archival and 3 rd party core-lab review Once the image data is received at the ACRIN Core Lab and all QC checks are completed, the imaging data is considered clean and is prepared for an independent core lab analysis. Imaging Site Checklist Reconstruct images using parameters as specified in the attachment. Review images to assess for artifacts and patient motion. Review images for excessive noise, low counts and subject positioning. List mode data will be rebinned into the 2 frames mentioned above. Archive the CTAC/transmission scan, all PET, raw and reconstructed study data including copies of the normalization and blank scans. These represent source data. 10

11 Complete the PET Technical Assessment Form (TA) while the study is being acquired and the Image Transmittal Worksheet (ITW) when the images are ready to be transmitted to ACRIN. Canthomeatal Plane 2 Inch Cohesive Tape Foam Wedge/Pillow 1. Supplies: 1.Standard Head Holder (manufacture specific- GE, Siemens, Philips) 2. Foam wedge for under the subject s legs (pillows can be used as a substitute) 3. Sheets or foam wedges (to secure head to limit side motion) 4. Blankets (for subjects comfort and warmth) 5. Place patient on table in supine position. Place the foam wedge under subject s knees for comfort (This will minimize patient discomfort, in turn reducing movement). Place blanket on patient for additional comfort. 6. Place subjects head in a standard head holder so that the Cantho-meatal plane line is vertical. Adjust positioning in head holder with foam wedges or folded sheets to obtain a fixed position. 7. Align patient using the gantry lasers to the central transverse, coronal and the sagittal planes. 8. ****SEE BELOW FOR POSTIONING 9. Strap patient s head in the holder using the 2 Inch Cohesive tape to affix proper positioning. Place tape over patient s forehead and complete the entire 10. ellipse of head three times to secure position and repeat the process for the patient s chin. 11. Check for inefficiencies in the taping and adjust accordingly. 12. Have patient s put their arms by their sides and strap them in lightly, have them remain in that position until imaging is complete. 13. Gentle continual contact with the patient during scan is imperative for communication and to assess for patient motion. Periodically update patient 11

12 regarding amount of time remaining and to maintain still at all times. If patient appears to be sleeping, there is no need to disturb them (this will lead to motion if patient is awaken) 1. Vertex 2. External Occipital Protuberance (E.O.P.) 3. External Auditory Meatus 4. Outer Canthus Of Eye. 5. Infra orbital point Positioning (PET/CT) 6. Nasion 7. Glabella The Orbital Meatal Line 3 4 (CanthomeatalPlane ) Positioning PET/CT Proper Patient positioning (Anatomically). Insure patient comfort prior to scan. Secure patients head in scanner (Motion) Followed exactly for all follow up exams(consistency) 12