{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T01:25:31Z","timestamp":1784769931131,"version":"3.55.0"},"reference-count":44,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2024,7,29]],"date-time":"2024-07-29T00:00:00Z","timestamp":1722211200000},"content-version":"vor","delay-in-days":210,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"TELIX Pharmaceuticals"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Glioblastoma (GBM), the most common malignant brain tumor, is associated with devastating outcomes. IPAX-1 was a multicenter, open-label, single-arm phase I study to evaluate carrier-added 4-L-[131I]iodo-phenylalanine ([131I]IPA) plus external radiation therapy (XRT) in recurrent GBM.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A total of 10 adults with recurrent GBM who had received first-line debulking surgery plus radio-chemotherapy, were randomized to a single-dose regimen (1f; 131I-IPA 2 GBq before XRT); a fractionated parallel dose regimen (3f-p; 3 131I-IPA 670 MBq fractions, in parallel with second-line XRT), or a fractionated sequential dose regimen (3f-s; 3 131I-IPA 670 MBq fractions before and after XRT). Metabolic tumor responses were determined using O-(2-[18F]fluoroethyl)-l-tyrosine positron emission tomography, while single-photon emission computed tomography was used to guide [131I]IPA tumor dosimetry.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>All dose regimens were well tolerated. Organ-absorbed radiation doses in red marrow (0.38 Gy) and kidney (1.28 Gy) confirmed no radiation-based toxicity. Stable disease was observed in 4 of the 9 patients at 3 months post-treatment (3-month follow-up [FU], 1 patient did not reach protocol-mandated end of study), yielding a response rate of 44.4%. At the 3-month FU, 6 patients demonstrated metabolic stable disease. Median progression-free survival was 4.3 months (95% confidence interval [CI]: 3.3\u20134.5), while median overall survival was 13 months (95% CI: 7.1\u201327).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Single or fractionated doses of [131I]IPA plus XRT were associated with acceptable tolerability and specific tumor targeting in patients with recurrent GBM, warranting further investigation.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/noajnl\/vdae130","type":"journal-article","created":{"date-parts":[[2024,7,26]],"date-time":"2024-07-26T17:55:27Z","timestamp":1722016527000},"source":"Crossref","is-referenced-by-count":8,"title":["Results from a phase I study of 4-<scp>\n                     <i>l<\/i>\n                  <\/scp>-[131I]iodo-phenylalanine ([131I]IPA) with external radiation therapy in patients with recurrent glioblastoma (IPAX-1)"],"prefix":"10.1093","volume":"6","author":[{"given":"Josef","family":"Pichler","sequence":"first","affiliation":[{"name":"Department of Internal Medicine and Neuro-oncology, Kepler University Hospital, Johannes Kepler University , Linz , Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatjana","family":"Traub-Weidinger","sequence":"additional","affiliation":[{"name":"Division of Nuclear Medicine, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna , Vienna , Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kurt","family":"Spiegl","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Ordensklinikum Linz Barmherzige Schwestern , Linz , Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Larisa","family":"Imamovic","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, Ordensklinikum Linz Barmherzige Schwestern , Linz , Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arthur J A T","family":"Braat","sequence":"additional","affiliation":[{"name":"Department of Radiology and Nuclear Medicine, University Medical Center Utrecht , Utrecht , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0857-081X","authenticated-orcid":false,"given":"Tom J","family":"Snijders","sequence":"additional","affiliation":[{"name":"Department of Neurology, University Medical Center Utrecht, Brain Center , Utrecht , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9673-0793","authenticated-orcid":false,"given":"Joost J C","family":"Verhoeff","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, University Medical Center Utrecht , Utrecht , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Flamen","sequence":"additional","affiliation":[{"name":"Department of Nuclear Medicine, Institut Jules Bordet, Universit\u00e9 Libre de Bruxelles , Brussels , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Libuse","family":"Tauchmanova","sequence":"additional","affiliation":[{"name":"TelixPharmaceuticals , North Melbourne, VIC , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colin","family":"Hayward","sequence":"additional","affiliation":[{"name":"TelixPharmaceuticals , North Melbourne, VIC , Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Kluge","sequence":"additional","affiliation":[{"name":"ABX - 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