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In response, a first\u2010in\u2010class peptide\u2010based radiotracer, [<jats:sup>68<\/jats:sup>Ga]Ga\u2010AJ206, is developed that can be seamlessly integrated into the standard clinical workflow and is specifically designed to noninvasively quantify CD38 levels and pharmacodynamics by positron emission tomography (PET). A bicyclic peptide, AJ206, is synthesized and exhibits high affinity to CD38 (<jats:italic>K<\/jats:italic><jats:sub>D<\/jats:sub>: 19.1 \u00b1 0.99\u00a0\u00d7 10<jats:sup>\u22129<\/jats:sup> <jats:sc>m<\/jats:sc>) by surface plasmon resonance. Further, [<jats:sup>68<\/jats:sup>Ga]Ga\u2010AJ206\u2010PET shows high contrast within 60 min and suitable absorbed dose estimates for clinical use. Additionally, [<jats:sup>68<\/jats:sup>Ga]Ga\u2010AJ206 detects CD38 expression in cell line\u2010derived xenografts, patient\u2010derived xenografts (PDXs), and disseminated disease models in a manner consistent with flow cytometry and immunohistochemistry findings. Moreover, [<jats:sup>68<\/jats:sup>Ga]Ga\u2010AJ206\u2010PET successfully quantifies CD38 pharmacodynamics in PDXs, revealing increased CD38 expression in the tumor following all\u2010trans retinoic acid (ATRA) therapy. In conclusion, [<jats:sup>68<\/jats:sup>Ga]Ga\u2010AJ206 exhibits the salient features required for clinical translation, providing CD38\u2010specific high\u2010contrast images in multiple models of MM. [<jats:sup>68<\/jats:sup>Ga]Ga\u2010AJ206\u2010PET could be useful for quantifying total CD38 levels and pharmacodynamics during therapy to evaluate approved and new therapies in MM and other diseases with CD38 involvement.<\/jats:p>","DOI":"10.1002\/advs.202308617","type":"journal-article","created":{"date-parts":[[2024,2,29]],"date-time":"2024-02-29T06:00:51Z","timestamp":1709186451000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["CD38\u2010Specific Gallium\u201068 Labeled Peptide Radiotracer Enables Pharmacodynamic Monitoring in Multiple Myeloma with PET"],"prefix":"10.1002","volume":"11","author":[{"given":"Ajay Kumar","family":"Sharma","sequence":"first","affiliation":[{"name":"The Russell H. 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Morgan Department of Radiology and Radiological Science Johns Hopkins University School of Medicine  Baltimore MD 21287 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian","family":"Marsh","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology and Molecular Sciences Johns Hopkins University School of Medicine  Baltimore MD 21287 USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dhiraj","family":"Kumar","sequence":"additional","affiliation":[{"name":"The Russell H. 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