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Research ArticleContinuing Education

Amyloid Imaging Update: How the Amyloid Landscape Is Changing in Light of the Recent Food and Drug Administration Approval of Antiamyloid Therapeutics

Barbara J. Grabher
Journal of Nuclear Medicine Technology December 2024, 52 (4) 314-325; DOI: https://doi.org/10.2967/jnmt.124.268329
Barbara J. Grabher
Grabher Consulting & Specialty Services, Forest Hill, Maryland
CNMT, RT(N), NCT FSNMMI-TS
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  • FIGURE 1.
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    FIGURE 1.

    Use of off-table head holder. (A) Canthomeatal line should be vertical and perpendicular to imaging table. (B) Even small deflections of canthomeatal line from vertical position can result in abnormal head tilt. (Reprinted from (22).)

  • FIGURE 2.
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    FIGURE 2.

    Patient positioning. (A) Body strap, knee cushion, and blanket applied for patient comfort. (B) Chin strap, head strap, and laser lights applied to position and secure head. Long arrow indicates laser light at level of patient’s ear, assisting in fixing table at proper height. Short arrow indicates laser light centered on patient’s head to keep it straight. (Courtesy of Barbara Grabher and Virtua Health System, Vorhees, NJ.)

  • FIGURE 3.
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    FIGURE 3.

    Examples of patient motion on static (A–C) and dynamic (D and E) images. (D) No motion. (E) Patient motion indicated by arrows. (F) Gold standard of motion-free negative (left) and positive images (right). Yellow arrows in A and B indicate thick scalp. Red arrow in C illustrates that tracer uptake does not reach the scalp. Blue arrow in C shows activity shifts (bright/dark) on same structure. Yellow arrows in F indicate scalp, and blue arrow indicates skull and cerebral spinal fluid. (A–C and F courtesy of Life Molecular Imaging; D and E reprinted from (23).)

  • FIGURE 4.
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    FIGURE 4.

    Normal and abnormal distribution patterns of uptake of 18F-florbetapir (A and B), 18F-flutemetamol (C–E), and 18F-florbetaben (G and H). Normal patterns of tracer uptake are similar where you can differentiate white matter from gray matter. In abnormal pattern of tracer uptake, you cannot differentiate white matter from gray matter. (F) Assessment of striatal binding, as required by FDA for Vizamyl only. White arrows denote level of transverse slice. Yellow dashed lines and arrowheads in G and H denote areas taken directly from florbetaben package insert. Cerebellum: contrast between white matter (arrows) and gray matter is seen in both negative and positive scans. Extracerebral tracer uptake in scalp and in posterior sagittal sinus (arrowhead) can be seen. Lateral temporal lobes: Spiculated or “mountainous” appearance of white matter (arrows) is seen in negative scan, and radioactive signal does not reach outer rim of brain (dashed line) because of lower tracer uptake in gray matter. Positive scan shows “plumped”, smooth appearance of outer border of brain parenchyma (dashed line) due to tracer uptake in gray matter. Frontal lobes: Spiculated appearance of white matter in frontal lobes (arrows) is seen in negative scan. Positive scan shows that tracer uptake in these regions has “plumped”, smooth appearance due to increased gray matter signal (dashed line). Posterior cingulate/precuneus: Adjacent and posterior to splenium (arrow), these regions appear as hypointense “hole” (circle) in negative scan, whereas this hole is “filled-up” (circle) in positive scan. Parietal lobes: In negative scan, midline between parietal lobes can be easily identified (long arrow); white matter has spiculated appearance (short arrow) with low signal near outer rim of brain (dashed line). In positive scan, midline between parietal lobes is much thinner. Cortical areas are “filled-up” and are smooth in appearance as tracer uptake extends to outer rim of brain. f = frontal; lt = lateral temporal; s = striatal region; pc = posterior cingulate region; cc = callosum; p = pons; ip = inferior parietal. (A and B reprinted from (1), C–E reprinted from (2), F reprinted with permission of (24), and G and H reprinted from (3).)

  • FIGURE 5.
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    FIGURE 5.

    AQ steps. (1) Coregistration of PET and MR images. (2) Segmentation of MR image. (3) Voxel-to-voxel intersection of segmented MR to predefined atlas to obtain individual regions of interest. (4) Application of individual regions of interest onto coregistered PET image and extraction of regional values. (Reprinted with permission of (7).)

  • FIGURE 6.
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    FIGURE 6.

    (A) How SUV and SUVRs are calculated for particular brain regions. (B) Defined reference regions and 7 defined target regions. (A courtesy of Life Molecular Imaging Medical Affairs; B reprinted with permission of (9).)

  • FIGURE 7.
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    FIGURE 7.

    Clarity AD study using centiloids (CLs) to document patient’s response to therapy. (A) Placebo subject images showing increase in CLs both at baseline and at 18 mo. (B) Lecanemab subject images showing decrease in CLs between baseline and 18 mo, indicating positive response to therapy. (C) Explanation of CL scale, (−20) to (+20), on scale indicative of amyloid-negative scan. CL levels above 35 indicate amyloid-positive scan. Gray zone of CL scale is where amyloid scan is not totally negative but also not totally positive. Gray zone is from (+21) to (+35). Upper levels of gray zone can help detect emerging amyloid plaques (arrow). (C reprinted with permission of (10); A and B reprinted with permission of Life Molecular Imaging.)

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    TABLE 1.

    Amyloid Imaging AUC Guidelines

    Clinical scenarioScore
    Appropriate use (scores of 7–9)
     5. Patients with MCI or dementia who are <65 y old and in whom AD pathology is suspected9
     6. Patients with MCI or dementia syndrome that is often consistent with AD pathology (amnestic presentation), with onset at ≥65 y8
     7. Patients with MCI or dementia syndrome that could be consistent with AD pathology but has atypical features (e.g., nonamnestic clinical presentation, rapid or slow progression, etiologically mixed presentation)8
     11. Patients with MCI or dementia with equivocal or inconclusive results on recent cerebrospinal fluid biomarkers8
     12. Patients with mild cognitive impairment due to clinically suspected AD pathology for whom information is needed to determine prognosis8
     14. Patients whose eligibility for treatment with approved amyloid-targeting therapy must be determined9
     15. Patients whose response must be monitored after receiving approved amyloid-targeting therapy8
    Uncertain use (scores of 4–6)
     4. Patients with subjective cognitive decline (cognitively unimpaired based on objective testing) who are considered at increased risk for AD based on age, known apolipoprotein E ɛ4 genotype, or multigenerational family history6
     13. Patients with dementia due to clinically suspected AD pathology for whom information is needed to determine prognosis4
    Rarely appropriate use (scores of 1–3)
     1. Patients cognitively unimpaired and not considered at increased risk for AD based on age, known apolipoprotein E ɛ4 genotype, or multigenerational family history1
     2. Patients cognitively unimpaired but considered at increased risk for AD based on age, known apolipoprotein E ɛ4 genotype, or multigenerational family history2
     3. Patients with subjective cognitive decline (cognitively unimpaired based on objective testing) who are not considered at increased risk for AD based on age, known apolipoprotein E ɛ4 genotype, or multigenerational family history2
     8. Patients with established biomarker-supported diagnosis of MCI or dementia due to AD pathology, for whom disease severity must be determined or disease progression tracked1
     9. Patients with prodromal Lewy body disease or dementia with Lewy bodies1
     10. Patients with MCI or dementia and recent cerebrospinal fluid biomarker results that are conclusive (whether consistent or not with underlying AD pathology)3
     16. For nonmedical use (e.g., legal, insurance coverage, or employment screening)1
     17. For use in lieu of genotyping, in patients who are suspected autosomal dominant mutation carriers1
    • Scenarios are numbered as in reference article (5). AUC are from (5).

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    TABLE 2.

    Amyloid Tracer Recommended Dose and Uptake time

    TracerRecommended doseUptake time (min)Acquisition time (min)Image displayNumber of regions for positive scan
    18F-florbetapir10 mCi (370 MBq)30–5010Gray scale or inverse gray scaleTwo, or only one if gray matter uptake exceeds white matter uptake
    18F-flutemetamol5 mCi (185 MBq)60–12010–20Rainbow color scaleOne
    18F-florbetaben8.1 mCi (300 MBq)45–13015–20Gray scale or inverse gray scaleOne
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    TABLE 3.

    Amyloid Imaging Acquisition Parameters

    ParameterSpecificationStandard/preferred/optional
    PET scanner type2- or 3-dimensionalStandard
    Energy peak511 keVStandard
    Energy window18F-fluorineStandard
    Patient positionSupine with head in off-table head holderStandard
    Acquisition areaWhole brain including cerebellumStandard
    Acquisition time18F-florbetapir, 10–15 min; 18F-flutemetamol, 10–20 min; 18F-florbetaben, 15–20 minStandard
    Number of bed positions1Standard
    • View popup
    TABLE 4.

    Amyloid Online Reader Training Information

    CompanyInformation
    Eli LillyReader training website: https://amyvid.lilly.com/hcp/reader-training
    Medical affairs support: https://medical.lilly.com/us/products
    Issues or questions: 800-545-5979, selecting options for nonmarketed products and 18F-florbetapir
    GE HealthCareReader training website: https://www.readvizamyl.com/
    Issues or questions: us.vizamyl{at}ge.com
    Life Molecular ImagingReader training website: https://www.neuraceqreadertraining.com/learn, obtaining registration access code at reader.training{at}life-mi.com
    Issues or questions: b.grabher{at}life-mi.com
    • View popup
    TABLE 5.

    Centiloid Equations for Converting SUVRs to Centiloids

    TracerEquation
    11C-Pittsburgh compound BCentiloids = 93.7 × SUVR − 94.6
    18F-florbetapirCentiloids = 175.4 × SUVR − 182.3
    18F-flutemetamolCentiloids = 121.4 × SUVR − 121.2
    18F-florbetabenCentiloids = 153.4 × SUVR − 154.9
    • View popup
    TABLE 6.

    Approved Amyloid PET Neuro Packages (FDA 510k and Conformité Européenne Mark)

    CompanyNeuro packageFeatures
    Syntermed, https://syntermed.com/neuroqNeuroQGenerates z scores and cortex–to–whole-cerebellum ratio based on standard SUVR
    Hermes Medical Solutions, https://www.hermesmedical.com/our-software/neurology/BRASSGenerates SUVR relative to whole cerebellum and z score based on reference database of 80 healthy controls (≥2 in region of interest is considered positive)
    MIM Software, https://www.mimsoftware.com/nuclear_medicine/mim_neuroMIMNeuroUses standardized PET template registration to generate voxel-based surface projections, regional and mean SUVR, and z score statistics without need for MRI; has also implemented centiloid scale across multiple tracers
    Siemens Healthineers, https://www.siemens-healthineers.com/digital-health-solutions/syngoviaSyngo.VIAUses positive SUVR cutoff of ≥1.17 and further cutoff of ≥1.08 to assess identifiable levels of amyloid plaques
    GE HealthCare, https://www.gehealthcare.com/courses/aw-cortex-idCortexIDGenerates SUVR and z score surface projection maps of individual patients
    Qubiotech, https://qubiotech.com/en/solutions/neurocloud-pet/Neurocloud PETGenerates individual SUVR using whole cerebellum as reference region
    • View popup
    TABLE 7.

    Contact Information for Amyloid PET Reimbursement and Imaging Support

    CompanyContact information
    Reimbursement services and support
     Eli Lilly800-545-5979; https://www.amyvid.com/hcp/support
     GE HealthCare844-225-1595
     Life Molecular ImagingReimbursement{at}life-mi.com
    Peer-to-peer image interpretation assistance
     Eli Lilly800-545-5979; https://www.amyvid.com/hcp/support
     GE HealthCare800-654-0118 (option 2, option 3); medical.affairs{at}gehealthcare.com
     Life Molecular ImagingMedinfo{at}life-mi.com
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Journal of Nuclear Medicine Technology: 52 (4)
Journal of Nuclear Medicine Technology
Vol. 52, Issue 4
December 1, 2024
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Amyloid Imaging Update: How the Amyloid Landscape Is Changing in Light of the Recent Food and Drug Administration Approval of Antiamyloid Therapeutics
Barbara J. Grabher
Journal of Nuclear Medicine Technology Dec 2024, 52 (4) 314-325; DOI: 10.2967/jnmt.124.268329

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Amyloid Imaging Update: How the Amyloid Landscape Is Changing in Light of the Recent Food and Drug Administration Approval of Antiamyloid Therapeutics
Barbara J. Grabher
Journal of Nuclear Medicine Technology Dec 2024, 52 (4) 314-325; DOI: 10.2967/jnmt.124.268329
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  • Article
    • Visual Abstract
    • Abstract
    • MECHANISM OF ACTION, PHARMACODYNAMICS, AND PHARMACOKINETICS
    • APPROPRIATE USE CRITERIA (AUC) FOR AMYLOID PET
    • CLINICAL INDICATION AND LIMITATIONS OF USE
    • PATIENT PREPARATION
    • DOSE AND ADMINISTRATION
    • ACQUISITION AND PROCESSING
    • TRACER DISTRIBUTION PATTERNS
    • IMAGE INTERPRETATION
    • WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS
    • USE IN SPECIAL PATIENT POPULATIONS
    • AQ AND CENTILOIDS
    • BENEFITS AND LIMITATIONS OF AMYLOID PET
    • MARKET ACCESS AND REIMBURSEMENT SUPPORT
    • CONCLUSION
    • DISCLOSURE
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Keywords

  • amyloid imaging
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