Introduction/Background SENTIX is a prospective, single-arm, international study of sentinel lymph node (SLN) biopsy without pelvic lymph node dissection (PLND) in patients with early-stage cervical cancer. We report the sensitivity of magnetic resonance imaging (MRI) and expert ultrasound (EUS) in preoperative clinical staging.
Methodology Forty-seven sites from 18 countries participated in the study. Patients with stages 1A1/LVSI+ to 1B2 (FIGO 2018), usual histological types, and no suspicious lymph nodes on imaging were prospectively enrolled between May 2016 and October 2020. One imaging method, either pelvic MRI or EUS, was mandatory for preoperative local staging and was chosen at the investigator’s discretion.
Results Among 690 prospectively enrolled patients fulfilling the inclusion criteria, MRI and EUS were performed as the staging imaging modality in 46.7% and 43.1% of patients, respectively, and 10.1% underwent both. Preoperatively unrecognized parametrial involvement was detected by pathology in 26 patients (3.8%) and SLN metastatic involvement in 68 (9.9%) patients, of which 54.4% and 45.6% had micrometastasis and macrometastasis, respectively, as the largest type of metastasis. MRI and EUS showed comparable sensitivity for tumour size measurement and for the failure to detect parametrial, or macrometastatic LN involvement (table 1). Combining both imaging methods did not increase the outcome (table 1).
Conclusion Pelvic MRI and EUS are equally sensitive methods for assessing clinically relevant parameters in preoperative clinical staging of cervical cancer, including tumour size, parametrial involvement, and macrometastatic nodal involvement.
Disclosures The authors declare no conflict of interest.
Trial registration ClinicalTrials.gov: NCT02494063
Funding This work was supported by Charles University in Prague (UNCE 204065 and PROGRES Q28/LF1) and by a grant from the Czech Health Research Council (NV19–03-00023). The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the presentation; or in the decision to publish the results.
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