{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T09:08:35Z","timestamp":1779872915682,"version":"3.53.1"},"reference-count":33,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,4,19]],"date-time":"2026-04-19T00:00:00Z","timestamp":1776556800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,4,19]],"date-time":"2026-04-19T00:00:00Z","timestamp":1776556800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100007469","name":"Alfred Benzon Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007469","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Physio Funct Imaging"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction Aim<\/jats:title>\n                    <jats:p>Fibroblast activation protein inhibitor (FAPI) has demonstrated promising oncological diagnostic performance. Although no adverse events (AEs) have been previously reported, a formal safety evaluation of FAPI PET\/CT is lacking. This study aimed to assess the safety and tolerability of [\u2076\u2078Ga]Ga\u2010FAPI\u201046 PET\/CT, with a focus on hemodynamic parameters, AEs, and patient\u2010reported discomfort.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>Participants were included from two ongoing prospective diagnostic trials: (1) FAPI PET\/CT in ovarian cancer (EU CTIS no. 2023\u2010505938\u201098\u201000) and (2) FAPI PET\/CT in gastric and gastroesophageal junction cancer (EU CTIS no. 2023\u2010505916\u201040\u201001). A dose of 150\u2013250 MBq [\u2076\u2078Ga]Ga\u2010FAPI\u201046 was administered, and low\u2010dose, non\u2010contrast CT was performed. Hemodynamic parameters, including systolic and diastolic blood pressure (BP) and heart rate (HR), were measured at baseline, 1\u2010min post\u2010injection (p.i.), 10\u2009min p.i., and post\u2010scan. Additionally, potential AEs and discomfort were assessed at these timepoints and 1 day p.i., and participants were instructed to report events. AEs were graded according to the Common Terminology Criteria for Adverse Events version 5.0.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Thirty participants were included. No patient reported AEs or discomfort attributable to [\u2076\u2078Ga]Ga\u2010FAPI\u201046, and no significant changes in mean systolic or diastolic BP were observed; however, three patients experienced increases in systolic BP classified as AEs. A clinically non\u2010relevant but statistically significant (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.01) decrease in HR (from 77 bpm at baseline to 73 bpm at post\u2010scan) was observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>[\u2076\u2078Ga]Ga\u2010FAPI\u201046 PET\/CT is well tolerated with no immediate patient\u2010reported discomfort or clinically relevant hemodynamic AEs. The observed decrease in HR from baseline to post\u2010scan likely reflects prescan nervousness.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/cpf.70064","type":"journal-article","created":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T04:51:39Z","timestamp":1776660699000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety of [\n                    <sup>68<\/sup>\n                    Ga]Ga\u2010FAPI\u201046 PET\/CT including hemodynamic measurements and patient\u2010reported outcomes in cancer patients"],"prefix":"10.1111","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6115-0967","authenticated-orcid":false,"given":"Morten","family":"Bentestuen","sequence":"first","affiliation":[{"name":"Department of Nuclear Medicine and Clinical Cancer Research Center Aalborg University Hospital Aalborg Denmark"},{"name":"Department of Clinical Medicine Aalborg University Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-8482-9943","authenticated-orcid":false,"given":"Camilla","family":"Sylvest","sequence":"additional","affiliation":[{"name":"Department of Gynaecology and Obstetrics Aalborg University Hospital Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8575-3703","authenticated-orcid":false,"given":"Svend B.","family":"Jensen","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine and Clinical Cancer Research Center Aalborg University Hospital Aalborg Denmark"},{"name":"Department of Chemistry and Bioscience Aalborg University Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lara R.","family":"Soro","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine and Clinical Cancer Research Center Aalborg University Hospital Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aage","family":"Knudsen","sequence":"additional","affiliation":[{"name":"Department of Gynaecology and Obstetrics Aalborg University Hospital Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0182-1228","authenticated-orcid":false,"given":"Morten","family":"Ladekarl","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine Aalborg University Aalborg Denmark"},{"name":"Department of Oncology and Clinical Cancer Research Center Aalborg University Hospital Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4963-1551","authenticated-orcid":false,"given":"Ole","family":"Thorlacius\u2010Ussing","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine Aalborg University Aalborg Denmark"},{"name":"Department of Gastrointestinal Surgery and Clinical Cancer Research Center Aalborg University Hospital Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5106-3584","authenticated-orcid":false,"given":"Wolfgang P.","family":"Fendler","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, West German Cancer Center, DKTK and NCT site University Hospital Essen Essen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9089-288X","authenticated-orcid":false,"given":"Helle D.","family":"Zacho","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine and Clinical Cancer Research Center Aalborg University Hospital Aalborg Denmark"},{"name":"Department of Clinical Medicine Aalborg University Aalborg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,4,19]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00259-024-06635-8"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12885-024-12461-w"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.semnuclmed.2023.11.003"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00259-014-2961-x"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00259-017-3728-y"},{"key":"e_1_2_9_7_1","unstructured":"National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v5.0. (2017);https:\/\/dctd.cancer.gov\/research\/ctep-trials\/for-sites\/adverse-events\/ctcae-v5-5x7.pdf."},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.2967\/jnumed.115.163865"},{"key":"e_1_2_9_9_1","volume-title":"Guideline on the non\u2010clinical requirements for radiopharmaceuticals","author":"EMA","year":"2018"},{"key":"e_1_2_9_10_1","volume-title":"ICH M3 (R2) Non\u2010clinical safety studies for the conduct of human clinical trials for pharmaceuticals \u2010 Scientific guideline","author":"EMA","year":"2013"},{"key":"e_1_2_9_11_1","volume-title":"Developing Medical Imaging Drug and Biological Products \u2010 Part 1: Conducting Safety Assessments","author":"FDA","year":"2004"},{"key":"e_1_2_9_12_1","unstructured":"FDA.FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs. (2025). 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