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Introduction to Theranostics

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Introduction to Theranostics Introduction to Theranostics Jonathan McConathy, M.D., Ph.D. Director, Division of Molecular Imaging and Therapeutics Co-Chair, Clinical Trials Network [email protected] November 8, 2018 Disclosures • Eli Lilly/Avid: Consulting, Research support • GE Healthcare: Consulting • Blue Earth Diagnostics: Consulting, Research support • Alphasource: Consulting (spouse) • Navidea: Research support (spouse) • AbbVie: Research support (spouse) FDA disclosure: Investigational tracers that are not FDA approved will be discussed. Off-label uses of FDA-approved tracers will be discussed. Examples of clinical nuclear medicine Cancer imaging Neuroimaging Hyperperfusion during Dopamine transporter epileptic seizure imaging Conventional Fluoride FDG DOTATATE Fluciclovine bone scan Amyloid and tau PET in Brain tumor imaging with Heart imaging Radionuclide therapy Alzheimer’s disease amino acid PET Sr-89 stress At-211 I-131 Ra-223 Sm-153 Ac-225 Lu-177 rest 13 Kratochwil C, et al., 2014. NH3-ammonia perfusion Radiopharmaceuticals • A radiopharmaceutical is a drug labeled with a radionuclide targeting biological process ‒ the overall chemical structure determines biological properties ‒ the radionuclide determines imaging and/or therapeutic properties Linker Pharmacophore Radiopharmaceuticals • A radiopharmaceutical is a drug labeled with a radionuclide targeting biological process ‒ the overall chemical structure determines biological properties ‒ the radionuclide determines imaging and/or therapeutic properties 18 D-glucose 2-deoxy-2-[ F]fluoro- D-glucose (FDG) PET (positron emission tomography) cameras detect the location and concentration of radioactive drugs in patients PET/MRI system [18F]FDG to detect increased sugar use by cancer Metastatic ovarian cancer on FDG-PET/MRI http://www3.gehealthcare.com/en/products/categories/magnetic_resonance_imaging/3-0t/signa_pet-mr Radionuclides • Unstable (radioactive) nuclei that decay over time decay ‒ Also called isotopes, radioisotopes, radiolabels ‒ Small subset are medically useful • Broad categories of radionuclides in nuclear medicine ‒ Single photon emitters (planar imaging, SPECT) Diagnostic radionuclides ‒ Positron emitters (PET) (photons) ‒ Beta minus emitters ‒ Auger emitters Therapeutic radionuclides ‒ Alpha emitters (particles) Imaging versus therapeutic radionuclides Photons for tissue penetration and diagnostic imaging Particulate radiation (electrons, alpha particles) for local energy/therapy deposition Beta and alpha particles damage DNA in radionuclide therapy Sr-89 Y-90 I-131 Sm-153 Lu-177 At-211 Ra-223 Ac-225 Kratochwil C, et al., 2014. 213Bi-DOTATOC receptor-targeted alpha-radionuclide therapy induces remission in neuroendocrine tumours refractory to beta radiation: a first-in-human experience. Eur J Nucl Med Mol Imaging, 41: 2106-19. Examples of radionuclides relevant to nuclear medicine Radionuclide Half-life Primary emission(s) Primary use Carbon-11 20.4 minutes positron PET Nitrogen-13 10 minutes positron PET Oxygen-15 122 seconds positron PET Fluorine-18 110 minutes positron PET Copper-64 12.7 hours positron, electron PET, (Therapy) Gallium-68 68 minutes positron PET Yttrium-90 64.6 hours electron Therapy, (PET) Technetium-99m 6.0 hours photon Planar, SPECT Indium-111 2.8 days photon Planar, SPECT Iodine-123 13.2 hours photon Planar, SPECT Iodine-124 4.2 days positron PET Iodine-131 8.0 days electron, gamma Therapy, Planar, SPECT Lutetium-177 6.7 days electron, gamma Therapy, SPECT Radium-223 11.4 days alpha Therapy Actinium-225 10 days alpha Therapy What are theranostics? What are theranostics? What are theranostics? • Therapeutic + Diagnostic = Theranostic ‒ diagnostic test to stratify patients by likelihood to respond to a specific treatment ‒ diagnostic test to monitor early response to treatment and predict efficacy • Concept has been around for a long time ‒ Radioiodine for the diagnosis and treatment of thyroid cancer (1940’s) ‒ Measuring estrogen and progesterone receptors and HER2 expression in breast cancer to guide hormonal and targeted therapy • In nuclear medicine, the same or very similar agent can serve as both a diagnostic and therapeutic agent ‒ Typical paradigm is to perform diagnostic imaging to determine if a patient would benefit form the therapeutic form of the agent ‒ Whole body imaging assess the entire tumor burden Theranostics and radionuclide therapy for cancer linker Pharmacophore 68Ga 1. Based on radiopharmaceuticals that localize to cancer cells to selectively deliver a DOTATATE therapeutic radionuclide. [[68177Ga]DOTATATELu]DOTATATE for for imaging imaging (NETSPOT) (Lutathera) 2. Often, a radiopharmaceutical can be labeled for imaging and for therapy: theranostic approach 3. Radionuclide therapies often have favorable adverse effect profile and can succeed after other therapies fail. 4. Imaging often guides therapy by demonstrating the entire tumor burden expresses the therapeutic target [68Ga]DOTATATE [177Lu]DOTATATE Sainz-Esteban, A, et al., 2012. Eur J Nucl Med Mol Imaging, 39: 501-11. Theranostics and radionuclide therapy for cancer linker Pharmacophore 177Lu 1. Based on radiopharmaceuticals that localize to cancer cells to selectively deliver a DOTATATE therapeutic radionuclide. [[68177Ga]DOTATATELu]DOTATATE for for imaging imaging (NETSPOT) (Lutathera) 2. Often, a radiopharmaceutical can be labeled for imaging and for therapy: theranostic approach 3. Radionuclide therapies often have favorable adverse effect profile and can succeed after other therapies fail. 4. Imaging often guides therapy by demonstrating the entire tumor burden expresses the therapeutic target [68Ga]DOTATATE [177Lu]DOTATATE Sainz-Esteban, A, et al., 2012. Eur J Nucl Med Mol Imaging, 39: 501-11. Examples of molecular imaging tied to radionuclide therapies Bone turnover Iodide transport in Somatostatin receptors Norepinephrine Prostate specific in skeletal differentiated in neuroendocrine transporter in membrane antigenin metastases thyroid cancer tumors neuroendocrine tumors prostate cancer [18F]fluoride [123/124131I]iodide [68Ga]DOTATATE [123I]MIBG [18F]DCFPyl 223 131 177 90 213 131 177 225 RaCl2, Na I [ Lu/ Y/ Bi]DOTATATE [ I]MIBG [ Lu/ Ac]PSMA [153Sm]EDTMP,89SrCl [225Ac]DOTATATE Neuroendocrine tumors (NETs) • NETs represent a wide range of neoplasm arising from neuroendocrine cells • Surgery is typically the only curative option • Treatment depends on the anatomic location, type of NET, and stage • Hormonally active tumors may cause significant morbidity and decrease quality of life • Radiopharmaceuticals play key roles for imaging and treating NETs Molecular imaging agents for NETs Somatostatin receptor ligands Norepinephrine transporter substrates [123/131I]MIBG [68Ga]DOTATATE Radiolabeled amino acids [18F]FDG [18F]FDOPA 5-hydroyx-L- [11C]tryptophan Somatostatin Receptors and Peptide Ligands Ala Gly Cys Lys Asn Phe Phe Human somatostatin Trp 14 amino acids Lys Thr Cys Ser Thr Phe PheCys Phe Octreotide D-Trp 8 amino acids Lys Thr Throl Cys Regulation of cell growth and hormone release Strosberg and Kvols, 2010. Antiproliferative effect of somatostatin analogs in gastroenteropancreatic neuroendocrine tumors. W J Gastroent, 16: 2963-2970. Sensitivity for NETs [68Ga]DOTATATE [18F]FDG van Essen, M, et al., 2014. Neuroendocrine tumours: the role of imaging for diagnosis and therapy. Nat Rev Endocrinol, 10: 102-14. 35 year old woman with atypical neuroendocrine tumor 68 [18F]FDG [ Ga]DOTATATE 34-year-old-woman with hepatic NET metastasis with no known primary tumor. [68Ga]DOTATE-PET/CT Prostate cancer continuum Active surveillance Higher serum PSA and faster PSA doubling time are associated with higher yield of PET imaging for biochemical recurrence Initial diagnosis, Detection and staging, and restaging of Selection of appropriate therapy biopsy guidance recurrence Monitoring response to therapy Serum PSA http://www.cancernetwork.com/oncology-journal/what-should-we-tell-patients-about-physical-activity-after-prostate-cancer-diagnosis Molecular imaging agents for prostate cancer Skeletal scintigraphy Metabolism Receptor ligands Na+ 18F- Sodium [11C]Choline and 99m Sodium [11C]acetate 18F-labeled derivatives [ Tc]MDP 18 [ F]fluoride Fatty acid metabolism and Membrane synthesis Mineralized bone turnover oxidative phosphorylation [18F]FDHT Androgen receptors PSMA ligands Bombesin derivatives Antibodies including Gastrin-related peptide [111In]capromab pendetide receptor (GRPR) [18F]FDG [18F]Fluciclovine Small molecule PSMA ligands Glycolysis Amino acid transport Prostate-specific Membrane Antigen (PSMA) Type II transmembrane protein Glutamate carboxypeptidase Associated with aggressive disease Present in solid tumor neovessels diagram Marker of androgen signaling Membrane Cytosol Curr Med Chem 2012 Slide courtesy of Marty Pomper MD, PhD (Johns Hopkins) and Steve Cho MD (University of Wisconsin-Madison) Selected PET tracers targeting PSMA DFO-89Zr [68Ga]PSMA-11 [89Zr]DFO-J591 [18F]DCFPyl Glu-NH-CO-NH-Lys-(Ahx)- [68Ga(HBED-CC)] [177Lu]PSMA-617 Lu-177 PSMA for radionuclide therapy Serial PSMA-PET scans to evaluate response Heck, MM, et al., 2016. Systemic Radioligand Therapy with 177Lu Labeled Prostate Specific Membrane Antigen Ligand for Imaging and Therapy in Patients with Metastatic Castration Resistant Prostate Cancer. J Urol, 196: 382-91. 2000 2018 1980 2018 Clinical trials demonstrating efficacy of radionuclide therapies ALSYMPCA Trial NETTER-1 Trial VISION Trial underway Ra-223 improves survival in Lu-177 DOTATATE improves progression- Lu-177 PSMA-617 for metastatic
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