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

Abstract

Background

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.

Methods

A proof-of-concept phase 2 study including 20 kidney cancer patients (ClinicalTrials.gov 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.

Results

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.

Conclusions

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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Funding

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.

Ethical approval

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: ClinicalTrial.gov 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). https://doi.org/10.1007/s00259-020-04936-2

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Keywords

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