Positron Emission Tomography (PET) Scan

PET Imaging Core: Procedures and Processes for Quality Control and Site Coordination. Positron Emission Tomography (PET) Scan: We propose to use same site qualifying, scanning and safety procedures being used in ongoing Alzheimer Disease Neuroimaging Initiative study (ADNI) of PET florbetapir. --- of our sites are already ADNI qualified sites. The non-ADNI sites will undergo additional qualification. PET Scanning Protocol: Florbetapir F18 is FDA approved for imaging brain beta- amyloid in subjects with progressive cognitive impairment and has been well studied in people in the age group we are proposing in this study. TAKE STUFF FROM WHAT I SENT YOU BEFORE Vitals (BP, pulse, RR) will be recorded before the scan and prior EKGs reviewed and any patients with significant deviations will not be scanned unless approved by the site nuclear medicine physician. (Because 18F-florbetapir may affect a fetus, pregnant or breast feeding women may not participate. Women of childbearing age will receive a urine test for pregnancy on the date of the scan.) DELETE THIS IF ONLY MEN ARE STUDIED Subjects will not receive research PET scans if he/she has received radiation therapy, or has been in another research study involving radiation that will cause them to exceed their safe limits, or if subject is pregnant or if they have been in a prior study of an amyloid active therapy. Subjects will be asked to refrain from sexual activity for 48 hrs after the scan. On rare occasions the insertion of a needle can cause bleeding, a blood clot, swelling or infection at the site of insertion. Study coordinator will call to check on subject safety 24-48 hrs (business days) following procedure and subject is told to call site for any emergent issues. Procedures for assuring scan quality: Our procedure for assuring scan quality are consistent with ADNI. Convert raw Image data to store on local computer. Raw Image Quality Control (QC) Process: 1. Visual inspection of all images: including both frames (temporal) and planes (spatial). 2. Extract and inspect all header information, and check versus required scan protocol. 3. Co-register (six degrees of freedom, rigid-body) all frames to first frame of the raw dynamic image set. Assess subject motion by magnitude of translation and rotation parameters. 4. Recombine co-registered frames to create both registered dynamic and registered average (averaged over all frames) image sets in native image geometry and orientation. 5. Determine image quality metrics (global correlation, global mean square error, global absolute error) both between frames on raw dynamic image data sets both pre- and post-co-registration. This includes comparisons between all frames pairs (e.g.15 comparisons for a 6-frame study). 6. Inspect PET scan information form completed by site for each scan. Note errors and correct. 7. Complete PET Quality Control (QC) form (e.g. pass, fail with reprocessing, fail with rescan, fail without rescan). In the event that the scan fails the quality control procedure and cannot be used, we will repeat the Florbetapir scan. When this protocol has been used in ADNI, to date, less than 5% of scans require a repeat. Positron Emission Tomography (PET) Scan: Site Qualification Procedures are similar to those used for ADNI. Each site will be qualified for PET. If the machine being used has already been certified for a recent florbetapir ADNI study within the past year and has not experienced any major software upgrades, then re-qualification will not be required. Sites will be provided with a Hoffman brain phantom (if one is not available to the site) and a technical manual for the data acquisition using 18F. The phantom must be scanned using the protocol identical to that in study to determine the characteristics of the scanner (particularly resolution and uniformity) and assure that sites are capable of performing the protocol for acquisition and image reconstruction. All phantom images will be forwarded to Duke Core QC group for review and qualification. CT Scan: Subject may also have a CT or PET transmission scan to correct PET images for attenuation. After the scans are completed subject will be asked to drink fluids and empty the bladder. If so, the CT or transmission scan also uses a very small dose of radiation. Positron Emission Tomography (PET) Scan: The total amount of radiation from the Florbetapir F18 PET scan, and associated “low dose” computer tomography (CT) scan performed as part of the PET scan, is approximately 7.0 mSv, equivalent to 2.5 years of background radiation in the U.S. ( 3 mSv/yr). Exposure to large amounts of radiation increases the risk of developing cancer. To date, Florbetapir F18 has been tested in approximately 2,200 people in completed and ongoing trials. The most common side effects were headache, injection site reactions, musculoskeletal pain, nausea and fatigue in the completed registration trials. Back pain, anxiety/claustrophobia, insomnia, hypertension, and neck pain were also reported. There were other adverse events, but none that occurred in more than one subject in the registration trials. Although the side effects from Florbetapir F18 noted so far have been relatively limited, subject may experience side effects that are not listed above. In the event that the scan fails the quality control procedure and cannot be used, we will repeat the Florbetapir scan. In ADNI to date, less than .5% of scans require repeat. Because of this, we include the total dose in the case of the necessity for repeating the scan once. A dosimetry table is available in the florbetapir package insert (www.amyvid.com). Reporting Serious Adverse Events related to Florbetapir PET: Any such experience due to any cause, regardless of the investigator‟s opinion of causation , which occurs during the course of the scan or within 30 days of it, is to be reported to the Duke Medical Director within 24 hours after learning of the event. This is in turn will trigger a report to be distributed to all participating sites, manufacturer (Eli Lilly), IRBs and the DOD per standard IND requirements. All SAEs are followed