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Phase I study to assess safety, biodistribution and radiation dosimetry for 89Zr-girentuximab in patients with renal cell carcinoma.
- Source :
- European Journal of Nuclear Medicine & Molecular Imaging; Sep2021, Vol. 48 Issue 10, p3277-3285, 9p, 2 Black and White Photographs, 3 Charts
- Publication Year :
- 2021
-
Abstract
- Purpose: In this phase I study, we evaluated the safety, biodistribution and dosimetry of [<superscript>89</superscript>Zr]Zr-DFO-girentuximab (<superscript>89</superscript>Zr-girentuximab) PET/CT imaging in patients with suspicion of clear cell renal cell carcinoma (ccRCC). Methods: Ten eligible patients received an intravenous administration of 37 MBq (± 10%) of <superscript>89</superscript>Zr-girentuximab at mass doses of 5 mg or 10 mg. Safety was evaluated according to the NCI CTCAE (version 4.03). Biodistribution and normal organ dosimetry was performed based on PET/CT images acquired at 0.5, 4, 24, 72 and 168 h post-administration. Additionally, tumour dosimetry was performed in patients with confirmed ccRCC and visible tumour uptake on PET/CT imaging. Results: <superscript>89</superscript>Zr-girentuximab was administered in ten patients as per protocol. No treatment-related adverse events ≥ grade 3 were reported. <superscript>89</superscript>Zr-girentuximab imaging allowed successful differentiation between ccRCC and non-ccRCC lesions in all patients, as confirmed with histological data. Dosimetry analysis using OLINDA/EXM 2.1 showed that the organs receiving the highest doses (mean ± SD) were the liver (1.86 ± 0.40 mGy/MBq), the kidneys (1.50 ± 0.22 mGy/MBq) and the heart wall (1.45 ± 0.19 mGy/MBq), with a mean whole body effective dose of 0.57 ± 0.08 mSv/MBq. Tumour dosimetry was performed in the 6 patients with histologically confirmed ccRCC resulting in a median tumour-absorbed dose of 4.03 mGy/MBq (range 1.90–11.6 mGy/MBq). Conclusions: This study demonstrates that <superscript>89</superscript>Zr-girentuximab is safe and well tolerated for the administered activities and mass doses and allows quantitative assessment of <superscript>89</superscript>Zr-girentuximab PET/CT imaging in patients with suspicion of ccRCC. Trial registration: NCT03556046—14th of June, 2018 [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 16197070
- Volume :
- 48
- Issue :
- 10
- Database :
- Complementary Index
- Journal :
- European Journal of Nuclear Medicine & Molecular Imaging
- Publication Type :
- Academic Journal
- Accession number :
- 152351701
- Full Text :
- https://doi.org/10.1007/s00259-021-05271-w