The role of 18F-FAZA PET/CT in detecting lymph node metastases in renal cell carcinoma patients: a prospective pilot trial



The accurate detection of nodal invasion is an unmet need in the clinical staging of renal cancer. Positron emission tomography (PET) with 18F-fluoroazomycin arabinoside (18F-FAZA), a hypoxia specific tracer, is a non-invasive imaging method that detects tumour hypoxia. The aim of this work was to evaluate the role of 18F-FAZA PET/CT in the identification of lymph node metastases in renal cancer.


A proof-of-concept phase 2 study including 20 kidney cancer patients ( Identifier: NCT03955393) was conducted. Inclusion criteria were one or more of the following three criteria: (1) clinical tumour size > 10 cm, (2) evidence of clinical lymphadenopathies at preoperative CT scan and (3) clinical T4 cancer. Before surgery, 18F-FAZA PET/CT was performed, 2 h after the intravenous injection of the radiotracer. An experienced nuclear medicine physician, aware of patient’s history and of all available diagnostic imaging, performed a qualitative and semi-quantitative analysis on 18F-FAZA images. Histopathological analysis was obtained in all patients on surgical specimen.


Fourteen/19 (74%) patients had a non-organ confined renal cell carcinoma (RCC) at final pathology (either pT3 or pT4). Median number of nodes removed was 12 (IQR 7–15). The rate of lymph node invasion was 16%. No patient with pN1 disease showed positive 18F-FAZA PET, thus suggesting the non-hypoxic behaviour of the lesions. In addition, neither primary tumour nor distant metastases presented a pathological 18F-FAZA uptake. No adverse events were recorded during the study.


18F-FAZA PET/CT scan did not detect RCC lymph neither nodal nor distant metastases and did not show any uptake in the primary renal tumour.

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The current study has been supported by a grant of Ministero Italiano della Salute—Ricerca Finalizzata. Protocol Study coding: FAZA RCC LNI Giovani Ricercatori (EudraCT Number: 2016-001774-15).

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Correspondence to Umberto Capitanio.

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Conflict of interest

Dr. Umberto Capitanio received grants/research supports, honoraria or consultation fees by the following: Ipsen, IBSA, Recordati, Konpharma.

Prof. Maria Picchio received GE Healthcare travel meeting support not related to the work.

The other authors declare no conflict of interest.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Clinical trial registrations: Identifier: NCT03955393: EudraCT number: 2016-001774-15

Co-last authors are Maria Picchio and Francesco Montorsi

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Capitanio, U., Pepe, G., Incerti, E. et al. The role of 18F-FAZA PET/CT in detecting lymph node metastases in renal cell carcinoma patients: a prospective pilot trial. Eur J Nucl Med Mol Imaging 48, 554–560 (2021).

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  • Kidney cancer
  • Renal cell carcinoma
  • Lymph node invasion
  • Imaging
  • PET
  • 18F-FAZA
  • Tumour hypoxia