Abstract
PurposeIn this phase I study, we evaluated the safety, biodistribution and dosimetry of [89Zr]Zr-DFO-girentuximab (89Zr-girentuximab) PET/CT imaging in patients with suspicion of clear cell renal cell carcinoma (ccRCC).MethodsTen eligible patients received an intravenous administration of 37 MBq (± 10%) of 89Zr-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.Results89Zr-girentuximab was administered in ten patients as per protocol. No treatment-related adverse events ≥ grade 3 were reported. 89Zr-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).ConclusionsThis study demonstrates that 89Zr-girentuximab is safe and well tolerated for the administered activities and mass doses and allows quantitative assessment of 89Zr-girentuximab PET/CT imaging in patients with suspicion of ccRCC.Trial registrationNCT03556046—14th of June, 2018
Highlights
Renal cell carcinoma (RCC) accounts for 5% and 3% of all cancers worldwide for men and women, respectively [1]
The study was open to patients who provided written informed consent and met the following eligibility criteria: patients with a clinical suspicion of primary clear cell RCC (ccRCC) or with established diagnosis of ccRCC suspected for recurrence or metastasis; at least 50 years old; and life expectancy of at least 6 months
Eight patients had a suspicion of a primary renal tumour and two patients had a suspicion of recurrence or metastasis of known ccRCC (Table 1)
Summary
Renal cell carcinoma (RCC) accounts for 5% and 3% of all cancers worldwide for men and women, respectively [1]. Renal tumours are diverse and their clinical behaviour is highly dependent on the histological subtype [2]. Clear cell RCC (ccRCC) is the most common subtype and accounts. CAIX can be effectively targeted by the chimeric monoclonal antibody girentuximab [9]. Multiple studies describe the high accuracy and clinical benefit of PET/CT imaging using radiolabeled girentuximab [124I]Igirentuximab (124I-girentuximab) and [89Zr]Zr-DFOgirentuximab (89Zr-girentuximab)) compared to CT imaging [10,11,12]. Animal studies demonstrate that 89Zrgirentuximab provides images with better contrast and spatial resolution compared with 124I-girentuximab due to an increased tumour retention of 89Zr [13, 14]
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