Preclinical evaluation of [225Ac]Ac-DOTA-TATE for treatment of lung neuroendocrine neoplasms.
Open accessAbstract
Purpose There is significant interest in the development of targeted alpha-particle therapies (TATs) for treatment of solid tumors. The metal chelator-peptide conjugate, DOTA-TATE, loaded with the β-particle emitting radionuclide 177 Lu ([177 Lu]Lu-DOTA-TATE) is now standard care for neuroendocrine tumors that express the somatostatin receptor 2 (SSTR2) target. A recent clinical study demonstrated efficacy of the corresponding [225 Ac]Ac-DOTA-TATE in patients that were refractory to [177 Lu]Lu-DOTA-TATE. Herein, we report the radiosynthesis, toxicity, biodistribution (BD), radiation dosimetry (RD), and efficacy of [225 Ac]Ac-DOTA-TATE in small animal models of lung neuroendocrine neoplasms (NENs).Methods [225 Ac]Ac-DOTA-TATE was synthesized and characterized for radiochemical yield, purity and stability. Non-tumor-bearing BALB/c mice were tested for toxicity and BD. Efficacy was determined by single intravenous injection of [225 Ac]Ac-DOTA-TATE into SCID mice-bearing human SSTR2 positive H727 and H69 lung NENs. RD was calculated using the BD data.Results [225 Ac]Ac-DOTA-TATE was synthesized with 98% yield, 99.8% purity, and displayed 97% stability after 2 days incubation in human serum at 37 °C. All animals in the toxicity study appeared healthy 5 months post injection with no indications of toxicity, except that animals that received ≥111 kBq of [225 Ac]Ac-DOTA-TATE had chronic progressive nephropathy. BD studies revealed that the primary route of elimination is by the renal route. RD calculations determined pharmacokinetics parameters and absorbed α-emission dosages from 225 Ac and its daughters. For both tumor models, a significant tumor growth delay and time to experimental endpoint were observed following a single administration of [225 Ac]Ac-DOTA-TATE relative to controls.Conclusions These results suggest significant potential for the clinical translation of [225 Ac]Ac-DOTA-TATE for lung NENs.
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In the first preclinical study for 225Ac-DOTATATE in lung NET xenograft, activity up to 111 kBq had no significant toxicity.
“1st Preclinical study for 225Ac-DOTATATE;Activity up to 111 kBq had no significant toxicity”
From Alpha-peptide receptor radionuclide therapy using actinium-225 labeled somatostatin receptor agonists and antagonists (2022) · cites this paper as [157]
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- Authors
- Tafreshi, N. K., Pandya, D. N., Tichacek, C. J., Budzevich, M. M., Wang, Z., Reff, J. N., Engelman, R. W., Boulware, D. C., Chiappori, A. A., Strosberg, J. R., Ji, H., Wadas, T. J., El-Haddad, G., & Morse, D. L.
- Affiliations
- Moffitt Cancer Center (US)
- University of Iowa Health Care (US)
- University of South Florida (US)
- Corresponding author
- El-Haddad, Ghassan
- Morse, David L.
- ORCID
- Venue
- European Journal of Nuclear Medicine and Molecular Imaging
- Published
- 2021-03-26
- Volume
- 48
- Issue
- 11
- Pages
- 3408-3421
- ISSN
- 1619-7070 (ISSN-L)
- 1619-7089
- PMC
- PMC12866175
- OpenAlex
- W3135969529
- Cited by
- 50
- References
- 42
- Citations by year
- 2026: 9 · 2025: 12 · 2024: 7 · 2023: 14 · 2022: 6 · 2021: 2
- FWCI
- 3.82
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- European Journal of Nuclear Medicine and Molecular Imaging (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- Funders
- Neuroendocrine Tumor Research Foundation
- H. Lee Moffitt Cancer Center and Research Institute
- National Cancer Institute (P30-CA076292)
- Topics
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiopharmaceutical Chemistry and Applications
- Health Sciences › Medicine › Epidemiology › Neuroendocrine Tumor Research Advances
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmaceutical Science › Chemical Reactions and Isotopes
- Keywords
- targeted alpha therapy, lung neuroendocrine tumors, somatostatin receptor 2, tissue distribution, radiation dosimetry, nephrotoxicity, alpha-emitting radionuclides
- MeSH terms
- Animals, Humans, Lung Neoplasms, Mice, Inbred BALB C, Organometallic Compounds, Tissue Distribution, Octreotide, Mice, SCID, Radiopharmaceuticals, Mice
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