IMAGE MANAGEMENT PLAN FOR ACRIN PA

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 (21Nov Version 1) Page 1

2 Table of Contents Letter of Introduction and Avid contacts 3 Imaging Site Responsibilities 4 Dose Ordering Procedure for 18 F-AV-45 5 Preparing Subject for 18 F-AV-45 PET scan 5 18 F-AV-45 PET scan Acquisition 6 File Naming Procedures 7 Brief Overview of Image QC 8 Query Process 9 Imaging Site Checklist 9 Attachment A Camera QA Log 10 Attachment B Avid Head Positioning and Restraint 11 Attachment C Reconstruction and Processing 13 Attachment D ACRIN Image Transmittal Worksheet (ITW) 14 Attachment E PET Technical Assessment Form (TA) 15 Page 2

3 Dear Imaging Site, This Image Management Plan (IMP) contains the technical instructions and guidelines on how to acquire the 18 F-AV-45 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 Avid PET images according to the imaging protocol within this document. These images must be then transmitted to the facility at ACRIN. Upon initial QC at ACRIN, these images are then transferred to a third-party independent core lab. At this time, Avid will also be provided with access to the images at the core-lab, where Avid will proceed to perform in depth technical QC on all the images. 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 18 F-AV-45 PET scan acquisition and submission. Although not required by protocol the imaging site is also requested to keep a running camera QA log that documents any changes made to the scanners. 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! Sincerely, The Avid Team Avid Imaging Operations/Sciences Jason Burns burns@avidrp.com Abhinay Joshi joshi@avidrp.com Catherine Veeraraj veeraraj@avidrp.com Avid Clinical Operations Kristen Zilker zilker@avidrp.com Mark Lowrey lowrey@avidrp.com ACRIN Core Lab Adam Opanowski (215) aopanowski@phila.acr.org Dena Flamini (215) dflamini@phila.acr.org Page 3

4 Imaging Site Responsibilities As part of the ACRIN PA 4003 study, the imaging site will perform Avid 18 F-AV-45 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, who will then submit all AV-45 images to Avid for quality control. In short the imaging site is expected to supply the following: Perform daily Camera QA Adhere to Proper Subject Positioning Image Acquisition 18 F-AV-45 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 or Avid for 18 F-AV-45 PET scans Daily Camera QA (ATTACHMENT A) To ensure scanner/ancillary equipment stability and quality throughout the project, each site is required to keep a daily Camera QA log (form at end of document). 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: 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 for AVID inspection. 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 Page 4

5 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 and the documents made available for Avid inspection. 18 F-AV-45 Dose Ordering Procedure Avid Radiopharmaceuticals, Inc. has provided a detailed guidance for the ordering of doses for this trial. Instructions and relevant forms are provided in the Clinical Supplies Guidance Document which will also be supplied to you. Preparing Subject for 18 F-AV-45 PET scan and Positioning (ATTACHMENT B) Remind your subjects that fasting is not necessary for an 18 F-AV-45 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. 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. Page 5

6 18 F-AV-45 PET Scan Acquisition Protocol (ATTACHMENT C) Please adhere to the following image acquisition protocol for acquiring, reconstructing and transmitting images to ACRIN. The subject will undergo 10 minutes of PET imaging starting 50 minutes following injection of 18 F-AV-45 and undergo vital sign assessments, ECG, blood and urine sampling. It is crucial to pay particular attention to ensuring the subject is comfortable on the imaging bed. The PET camera should be set up to two serial 5 min acquisitions, starting at 50 min post 18 F-AV-45 injection. A measured attenuation using a transmission source or CT (for PET CT units) will be performed either prior to the 18F-AV-45 injection or at the end of the study. Be mindful of the requirements outlined in the protocol for safety assessments, including ECG, vital signs, blood and urine sampling. Following bolus intravenous administration of 18 F-AV-45, subjects will have 2 x 5 minute continuous PET acquisitions to characterize to regional brain uptake between 50 and 60 min post injection. Subject positioning is a key component 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 that the patient can comfortably maintain that position throughout the duration of the scanning session. Obtain intravenous access using a small butterfly needle (Needles provided by AVID). Complete EKGs and obtain blood samples as described in the clinical protocol. Draw approximately 10 mci (370 MBq) of 18 F-AV-45 and assay with a dose calibrator. Record assay results and assay time. Inject the 18 F-AV-45 as a single bolus utilizing the Avid supplied injection kit (22g, 24g butterfly, 2 X 10ml saline flush syringes) within 20 seconds followed by a post injection residual value assay of the butterfly, tubing and dose syringe. Record the residual amount and time of assay. Apply net dose value to the acquisition header for correct dose delivery. Have subject relax post injection for a 50 minute dose circulation time prior to the imaging session. Once 45 minutes have elapsed, have the subject empty their bladder prior to the imaging session. Post Void, position and secure the subject in the scanner using the AVID positioning protocol. Acquire 2 X 5 minute images per AVID s acquisition/reconstruction parameters. Once the 2 X 5 minute acquisitions are complete, promptly assess for any technical failures (e.g. Motion, loss of data, artifacts etc.) Page 6

7 If any technical failure occurs, re-image patient for 2 X 5 minute images per AVID s acquisition/reconstruction parameters. Once imaging is complete and satisfactory (no motion, artifacts) sum the two 5 minute images into one 10 minute image frame. Once the imaging session is complete: All images will be corrected using measured attenuation. PET only 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 18 F-AV-45 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 Page 7

8 Brief Overview of Image QC by ACRIN, Avid and 3 rd party core-lab Avid Imaging Sciences/Operations will review imaging data that is sent to ACRIN and subsequently to the 3 rd party core lab to ensure that sites are adhering to the protocol and achieving optimal image quality. 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 (with assistance from Avid) 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. ACRIN and Avid will review AV-45 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 with Avid a plan of action. Avid is responsible for monitoring the activities at the core lab via regular teleconferences. Avid monitors and imaging staff will conduct periodic audits at the core lab to assess systems and processes and ensure the core lab s compliance with responsibilities. Page 8

9 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. Outstanding queries not resolved within two weeks will be reported to Avid via so that Avid can determine what further action can be taken to resolve the matter 5. 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. 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.. Page 9

10 ATTACHMENT A ACRIN PA 4003 Site Number: Site Name: Camera: Date 01-Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov Nov-2008 Daily Camera QC Check Staff Initials Comments/Notes (eg. camera service, new flood tables, software updates, preventative maintenance, power outages, back-up camera use, etc.) Page 10

11 ATTACHMENT B Avid Head Positioning and Restraint 18 F-AV-45 PET scan Patient positioning and head restraint prior to imaging Canthomeatal Plane 2 Inch Cohesive Tape Foam Wedge/Pillow 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) 1. 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. 2. 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. 3. Align patient using the gantry lasers to the central transverse, coronal and the sagittal planes. ****SEE BELOW FOR POSTIONING 4. 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 ellipse of head three times to secure position and repeat the process for the patient s chin. 5. Check for inefficiencies in the taping and adjust accordingly. 6. Have patient s put their arms by their sides and strap them in lightly, have them remain in that position until imaging is complete. 7. Gentle continual contact with the patient during scan is imperative for communication and to assess for patient motion. Periodically update patient 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) Page 11

12 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) Page 12

13 ATTACHMENT C Avid 18 F-AV-45 PET scan - Image Reconstruction and Processing CT scan (transmission scan acquisition and reconstruction protocol): A low-dose CT acquisition of the head is acquired using the following parameters: Tube voltage: 120 kvp Automated dose reduction: Auto mas Acquisition type: Spiral Pitch: 0.8 Collimation: 1.2 mm Slice Thickness: 5 mm Slice Interval: 3 mm Rotation: 0.5 sec SFOV for transmission scan: 500 mm Reconstruction Kernel: B19F (very smooth) Image matrix: 512 x 512 PET Emission Acquisition & Reconstruction Protocol: Scanning direction: Head to foot # Of Beds: 1 (brain) Time per Scan: 2 x 5 min scans Randoms Correction: On (Prompts Delays) Scatter correction: On Decay Correction: On Attenuation Correction: CT or rod transmission source Reconstruction Algorithm: Iterative 4 iterations, 16 subsets Image Matrix Size: 128 X 128 Zoom: 2 Slice Thickness: 5mm Post reconstruction Filter: Gaussian FWHM 5.0mm Page 13

14 Attachment D ACRIN PA 4003 Image Transmittal Worksheet 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 Instructions: Imaging exams should be submitted to the ACRIN-Image Management Center after each time-point/visit. A completed, signed Image Transmittal Worksheet MUST accompany all imaging exams submitted to ACRIN for each time-point. For exams submitted via the internet, complete this worksheet and to imagearchive@phila.acr.org or fax to For exams submitted via media, complete this worksheet and include with the media shipment. Please affix a label to the jacket of the media to include: study name, site name, and case number, date of exam, time point, and type of imaging. THIS FORM MUST BE COMPLETED IN ITS ENTIRETY FOR THE CASE TO BE CREDITED. *Reminder for PET imaging: All PET exams should contain three trans-axial series, attenuated and nonattenuated corrected PET and CT or transmission images. For further information or questions contact the Image Management Center at ACRIN. Section I: Image Data Demographics ACRIN Site Number: CTEP Number: (A A N N N) Participant DOB: ACRIN Case Number: Participant Initials: (F M L) Section II: Image Submission Date of Study: Electronic Transfer [ 11 C]PIB [ 18 F]-AV-45 MRI Imaging Exam # of Series Non-Atten. Corr. PET # Images per series (nnn/nnn/nnn) Date of Imaging (MM-DD-YYYY) PET/CT Atten. Corr. PET CT PET MRI Institution Comments: Form Completed By: Phone: Date: ACRIN Image Archive American College of Radiology 1818 Market Street, Suite 1600 Philadelphia, PA ATTN: ACRIN 4003 American College of Radiology Image Management Center ACRIN PA 4003 Worksheet ID: (IT)

15 TA ACRIN PA 4003 Evaluation of [ 18 F]-AV-45 to Distinguish Patients with a Clinical Diagnosis of Alzheimer s Disease from Cognitively Normal Individuals Attachment E Institution ACRIN Study PA 4003 PLACE LABEL HERE Institution No. If this is a revised or corrected form, please box. Participant Initials Case No. PET TECHNICAL ASSESSMENT Instructions: This form is to be completed, by the Technologist, for each amyloid ligand as specified in the protocol. All images are tobe transmitted to ACRIN as detailed in the study protocol. All times must be reported in military format (i.e., 2:45pm = 1445 hours). NOTE: Any protocol deviations that occur during the scan need to be recorded on a PR form. This form is submitted to ACRIN via web at Section I. Scan 1. This TA form corresponds to: [1] O 1[ 11 C] - PIB O 2[ 18 F] - AV Was the scan conducted? [2] (continue to question 2a) O 2 Yes (continue to question 3) 2a. Reason why the scan was not conducted: (check all that apply, then initial and date form) Illness [3] Participant unavailable [4] Participant unwilling [5] Administrative problems [6] Withdrawn consent (complete DS form) [7] Other, [8] specify 3. Scan date - - (mm-dd-yyyy) [10] 4. Technologist initials: [11] 5. Select one of the following scanner and vendor models: [12] O 1. GE (complete question 5a) 5a. If GE, scanner model [13] O 1 Advance O 2 Discovery LS O 3 Discovery ST O 4 Discovery RX O 5 Discovery STE O 2. Siemens/CTI (complete question 5b) 5b. If Siemens/CTI, scanner model [14] O 1 ACCEL O 2 Biograph O 3 BioGraph BGO O 4 BioGraph HiRez O 5 EXACT O 6 HR+ O 7 HRRT O 3. Phillips (complete question 5c) 5c. If Phillips, scanner model [15] O 1 Allegro O 2 Allegro-Neuro O 3 Gemini O 4 Gemini GLX O 5 Gemini-TF "Copyright 2008" [9] 6. Time of today's Scanner QC : : HH:MM:SS [16] Unknown [17] Enter '00' for seconds portion of the time if seconds are unavailable. 7. Time of dose assay : : HH:MM:SS [18] Unknown [19] Enter '00' for seconds portion of the time if seconds are unavailable. 7a. Dose assay to nearest 0.1. mci [20] Unknown [21] 8. Time of residual assay : : HH:MM:SS [22] Unknown [23] Enter '00' for seconds portion of the time if seconds are unavailable. 8a. Residual left in syringe if > 0.1. mci [24] Unknown [25] 9. Net injected dose. [26] corrected for residual activity to nearest 0.1 mci Unknown [27] 9a. Volume ml [28] Unknown [29] 10. Time of injection : : HH:MM:SS [30] Unknown [31] Enter '00' for seconds portion of the time if seconds are unavailable. If this form corresponds to the [ 18 F]-AV-45 Scan, please complete Q11 and Q12, otherwise skip to Q Blood pressure before scan (systolic/diastolic) / mmhg [32] Unknown [33] ACRIN 4003 TA of 3

16 TA ACRIN PA 4003 Evaluation of [ 18 F]-AV-45 to Distinguish Patients with a Clinical Diagnosis of Alzheimer s Disease from Cognitively Normal Individuals If this is a revised or corrected form, please box. ACRIN Study PA 4003 PLACE LABEL HERE Institution Institution No. Participant Initials Case No. 12. Pulse before scan: bpm [34] 20. Predefined acquisition protocol ID Unknown [35] 13. Time scan started (emission) : : HH:MM:SS [36] Unknown [37] Enter '00' for seconds portion of the time if seconds are unavailable. 14. Time scan ended (emission) : : HH:MM:SS [38] Unknown [39] Enter '00' for seconds portion of the time if seconds are unavailable. If this form corresponds to the [ 18 F]-AV-45 Scan, please complete Q15 and Q16, otherwise skip to Q Blood pressure after scan (systolic/diastolic) / mmhg [40] Unknown [41] 16. Pulse after scan: bpm [42] Unknown [43] 17. Provide an explanation if start time is not within the allowable window. [ 18 F] - AV-45 Target = 50 minutes post injection [ 11 C] -PIB-Target = 50 minutes post injection 21. Indicate whether scan was static or dynamic: [49] O 1 Static (1x20 min) O 2 Standard Dynamic (4x5 min) O 3 Dynamic (6x5 min) O 4 Dynamic, specify 22. Subject motion problems [51] O 2 Yes (complete question 22a) 22a. If yes, describe 23. Scanner malfunction [53] O 2 Yes (complete question 23a) 23a. If yes, describe 24. Other protocol variations [55] O 2 Yes (complete PR form) Section III. Scan Reconstruction 25. Check which of the following reconstructions was used: [56] O 1 FORE/2D-OSEM (complete Q25a, Q25a1, Q25d, Q26) O 2 OSEM3D-OP (complete Q25a, Q250a1) O 3 3D-Ramla (complete Q25a, Q250a1, Q25b) O 4 3D Back-projection (complete Q25c) [48] [50] [52] [54] 18. Is this the participants second amyloid ligand PET study? [45] (continue to Q19) O 2 Yes (continue to 18a) 18a. Were both scans performed on the same scanner? [46] (complete a PR form) O 2 Yes (continue to Q19) Section II. Scan Protocol Information 19. Any variations from protocol during uptake? [47] O 2 Yes (complete PR form) [44] 25a. If OSEM or Ramla, number of subsets: [57] O 1 14 O 2 16 O 88 Other, specify 25a1. Number of iterations: [59] O 1 2 O 2 4 O 3 6 O 88 Other, specify 25b. If Ramla, Lambda = 0.016? [61] O 2 Yes [58] [60] "Copyright 2008" ACRIN 4003 TA of 3

17 TA ACRIN PA 4003 Evaluation of [ 18 F]-AV-45 to Distinguish Patients with a Clinical Diagnosis of Alzheimer s Disease from Cognitively Normal Individuals If this is a revised or corrected form, please box. ACRIN Study PA 4003 PLACE LABEL HERE Institution Institution No. Participant Initials Case No. 25c. If Back projection, ramp filter? [62] O 2 Yes 25d. If FORE/2D-OSEM, Brain Mode "on" for PET only scanners or TRIM "on" for PET/CT scanners? [63] O 2 Yes 26. No post-process smoothing: [64] O 2 Yes 27. Decay Correction [65] O 2 Yes 28. Scatter Correction [66] O 2 Yes 29. Attenuation Correction [67] O 1 CT O 2 Ge-68+Segmentation O 3 Cs-137+Segmentation Section IV. Images Transfer 30. Were images transferred to ACRIN? [68] (complete question 30b) O 2 Yes (complete question 30a then continue to question 31) 30a. Transfer Date - - [69] (mm-dd-yyyyy) If your site is unable to complete the transfer please indicate the problem in question 30b. 30b. Reason images not transferred to ACRIN: Section V. Adverse Events 31. Were any AE's associated with this scan? [71] O 2 Yes (please complete AE form) [70] COMMENTS: [72] Initials of Technologist - - [73] [74] Date form completed (mm-dd-yyyy) Initials of person(s) completing this form "Copyright 2008" [75] ACRIN 4003 TA of 3