pone.0294564.g003.tif (664.73 kB)

[⁶⁸Ga]FAPI-46 drug product manufacturing process diagram.

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posted on 2023-11-27, 18:35 authored by Aashna Karbhari, Sherly Mosessian, Kamaxi H. Trivedi, Frank Valla Jr, Mark Jacobson, Mark J. Truty, Nandakumar G. Patnam, Diane M. Simeone, Elcin Zan, Tracy Brennan, Hongli Chen, Phillip H. Kuo, Ken Herrmann, Ajit H. Goenka

[⁶⁸Ga]FAPI-46 drug product manufacturing process diagram.

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widespread metastatic dissemination safety profile validation pancreatic ductal adenocarcinoma new drug application meeting fda requirements lethal disease prone fibroblast activation protein current study seeks curative surgical resection profile caf identity initial diagnostic biopsy improved patient outcomes 60 adult treatment resected tumor samples baseline pet scan cohort 2 ).open label non mediated therapy resistance assess predictive values 68 cohort 2 patients nat [< sup gov identifier nct05262855 [< sup treatment resistance phase 2 cohort 1 poor outcomes overcoming caf neoadjuvant therapy gov identifier diagnostic performance tumor stroma tumor growth additional pet versus post truth standards stakeholder expectations single arm secondary objectives primary objective naïve patients mitigate risks invasive tools influencing carcinogenesis image fap fap immunohistochemistry exploratory objectives detecting fap desmoplastic stroma crucial components completing nat coherent strategy clinical translation care imaging associated fibroblasts 46 pet

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