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Research ArticleContinuing Education

SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer—Use of Imaging Agents in Therapeutic Drug Development and Approval

Charlotte Denise Jeffers, Courtney Lawhn-Heath, Regan I. Butterfield, John M. Hoffman and Peter J.H. Scott
Journal of Nuclear Medicine Technology December 2022, 50 (4) 291-300; DOI: https://doi.org/10.2967/jnmt.122.264372
Charlotte Denise Jeffers
1Department of Radiology, University of Alabama at Birmingham, Birmingham, Alabama;
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Courtney Lawhn-Heath
2Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, California;
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Regan I. Butterfield
3Center for Quantitative Cancer Imaging, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah;
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John M. Hoffman
3Center for Quantitative Cancer Imaging, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah;
4Department of Radiology and Imaging Sciences, University of Utah School of Medicine, Salt Lake City, Utah; and
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Peter J.H. Scott
5Department of Radiology, University of Michigan, Ann Arbor, Michigan
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  • FIGURE 1.
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    FIGURE 1.

    Drug development process. A(NDA) = abbreviated NDA; cGMP = current good manufacturing practice; CMS = Centers for Medicare and Medicaid Services.

  • FIGURE 2.
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    FIGURE 2.

    Representative coronal small-animal PET images of control animal imaged with 18F-AH114726 at baseline and after displacement with 1 mg/kg dose of flumazenil. (Reprinted with permission of (26).)

  • FIGURE 3.
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    FIGURE 3.

    18F-FDG PET maximum-intensity projections (A–C), axial PET images (D–F), and axial CT images (G–I) through pelvis in patient with metastatic GIST. Normal physiologic 18F-FDG uptake is seen in urinary collecting system in both kidneys (kd), in myocardium (my), and in bladder (bl). (A) Intense 18F-FDG uptake is seen in left lower pelvis and contiguous to right proximal ureter (TU) at baseline before imatinib therapy, consistent with metastatic GIST. (B) Resolution of abnormal 18F-FDG uptake is noted in both tumor masses as early as 1 wk after treatment. (C) Continuous metabolic response to imatinib is seen in this patient 2 mo after initiation of therapy despite presence of residual mass on CT. (Reprinted with permission of (29).)

  • FIGURE 4.
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    FIGURE 4.

    18F-florbetapir (Amyvid) amyloid PET images at baseline and 1 y after aducanumab treatment, showing amyloid plaque reduction after different doses of aducanumab but not placebo. (Reprinted with permission of (30).)

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    FIGURE 5.

    (Left) 18F-FEOBV PET, MR, and overlay images from healthy control subject. (Reprinted from (35).) (Right) Age-related reduced Vesicular acetylcholine transporter binding reductions (Reprinted from (39).)

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    FIGURE 6.

    68Ga-PSMA-11 PET before and after treatment with 177Lu-PSMA-617. (Reprinted from (42).)

  • FIGURE 7.
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    FIGURE 7.

    (Left) 18F-SPARQ PET images of subject who received 100 mg of aprepitant: predosing (top row) and postdosing (bottom row) are shown, with estimated receptor occupancy of 94%. (Right) Relationship between plasma concentration of aprepitant and receptor occupancy. NK1 = neurokinin-1. (Reprinted with permission of (45).)

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    TABLE 1.

    Overview of Clinical Trial Process

    PhaseNo. of subjectsScope
    0/IFew dozen (therapeutic); 10–30 (diagnostic)New drug is first given to small number of people; studies might be exploratory, involving several candidate molecules to select lead for development (46), and are intended to demonstrate safety of new agent and dose-limiting toxicity
    IIFew hundred (therapeutic); 20–40 (diagnostic)Study is undertaken to demonstrate proof of efficacy and to reveal less common side effects; if enough patients benefit from new drug, and side effects are acceptable, then phase III trials can be initiated; additional safety data are obtained
    IIISeveral hundred (therapeutic); 50–100 (diagnostic)Trials are intended to compare safety and efficacy of new diagnostic or therapeutic agent against standard of care and typically are large and multicenter; research subjects are picked at random to receive standard of care or new treatment; when neither doctor nor subject knows which treatment subject is getting, trial is considered double-masked; additional safety data are obtained, and if new drug is found to be as effective as or more effective than existing drugs, or is safer, NDA can be submitted to FDA
    IVThousandsPostapproval studies are intended to monitor FDA-approved drugs over long period (e.g., several years)
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    TABLE 2.

    Radiopharmaceuticals Used in Clinical Trials

    TypeExamples
    FDA-approved imaging radiopharmaceuticals*18F-FDG
    18F-florbetapir (Amyvid)
    18F-florbetaben (Neuraceq)
    18F-flutemetamol (Vizamyl)
    18F-flortaucipir (Tauvid)
    68Ga-DOTATATE (NETSPOT; Advanced Accelerator Applications)
    64Cu-DOTATATE (Detectnet; Curium US LLC)
    68Ga-PSMA-11 (University of California San Francisco and UCLA)
    18F-DCFPyL (Pylarify; Progenics Pharmaceuticals, Inc.)
    123I-ioflupane (DaTscan; GE Healthcare)
    18F-fluciclovine (Axumin; Blue Earth Diagnostics)
    8F-fluroestradiol (Cerianna; Zionexa US Corp.)
    99mTc-sestamibi
    18F-fluorodopa (Feinstein Institutes for Medical Research)
    68Ga-PSMA-gozetotide (Locametz; Novartis)
    FDA-approved therapeutic radiopharmaceuticals177Lu-DOTATATE (Lutathera; Advanced Accelerator Applications)
    177Lu-PSMA-617 (Pluvicto; Novartis)
    Investigational agents for research under RDRC or IND11C-Pittsburgh compound B
    18F-fluorothymidine
    18F-FEOBV
    Investigational imaging and therapeutic agents for commercialization18F-flupiridaz (imaging)
    225Ac-PSMA-617 (therapy)
    Investigational radiotracers to support therapeutic trials (e.g., receptor occupancy)18F-SPARQ
    Radiolabeled drugs or drug candidates11C-ibrutinib
    11C-docetaxel
    18F-lansoprazole
    • ↵* For diagnosis, staging, and monitoring of therapy or as biomarker or surrogate endpoint.

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Journal of Nuclear Medicine Technology: 50 (4)
Journal of Nuclear Medicine Technology
Vol. 50, Issue 4
December 1, 2022
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SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer—Use of Imaging Agents in Therapeutic Drug Development and Approval
Charlotte Denise Jeffers, Courtney Lawhn-Heath, Regan I. Butterfield, John M. Hoffman, Peter J.H. Scott
Journal of Nuclear Medicine Technology Dec 2022, 50 (4) 291-300; DOI: 10.2967/jnmt.122.264372

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SNMMI Clinical Trials Network Research Series for Technologists: Clinical Research Primer—Use of Imaging Agents in Therapeutic Drug Development and Approval
Charlotte Denise Jeffers, Courtney Lawhn-Heath, Regan I. Butterfield, John M. Hoffman, Peter J.H. Scott
Journal of Nuclear Medicine Technology Dec 2022, 50 (4) 291-300; DOI: 10.2967/jnmt.122.264372
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  • Article
    • Abstract
    • TYPES OF IMAGING STUDIES CONDUCTED DURING DRUG DEVELOPMENT PROCESS
    • REGULATORY CONSIDERATIONS
    • TYPES OF RESEARCH STUDIES
    • HOW RADIOPHARMACEUTICALS CAN BE DEPLOYED IN RESEARCH
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Keywords

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