Abstract
Radioisotope-guided sentinel lymph node dissection (sLND) has shown high diagnostic reliability in prostate (PCa) and other cancers. To overcome the limitations of the radioactive tracers, magnetometer-guided sLND using superparamagnetic iron oxide nanoparticles (SPIONs) has been successfully used in PCa. This prospective study (SentiMag Pro II, DRKS00007671) determined the diagnostic accuracy of magnetometer-guided sLND in intermediate- and high-risk PCa. Fifty intermediate- or high-risk PCa patients (prostate-specific antigen (PSA) ≥ 10 ng/mL and/or Gleason score ≥ 7; median PSA 10.8 ng/mL, IQR 7.4–19.2 ng/mL) were enrolled. After the intraprostatic SPIONs injection a day earlier, patients underwent magnetometer-guided sLND and extended lymph node dissection (eLND, followed by radical prostatectomy. SLNs were detected in in vivo and in ex vivo samples. Diagnostic accuracy of sLND was assessed using eLND as the reference. SLNs were detected in all patients (detection rate 100%), with 447 sentinel lymph nodes SLNs (median 9, IQR 6–12) being identified and 966 LNs (median 18, IQR 15–23) being removed. Thirty-six percent (18/50) of patients had LN metastases (median 2, IQR 1–3). Magnetometer-guided sLND had 100% sensitivity, 97.0% specificity, 94.4% positive predictive value, 100% negative predictive value, 0.0% false negative rate, and 3.0% additional diagnostic value (LN metastases only in SLNs outside the eLND template). In vivo, one positive SLN/LN-positive patient was missed, resulting in a sensitivity of 94.4%. In conclusion, this new magnetic sentinel procedure has high accuracy for nodal staging in intermediate- and high-risk PCa. The reliability of intraoperative SLN detection using this magnetometer system requires verification in further multicentric studies.
Highlights
Histopathological examination or pelvic lymph node (LN) dissection (LND) is still the gold standard for LN staging in clinically localized prostate cancer (PCa)
The natural dark brown color can help to further identify sentinel LN (SLN) intraoperatively and eliminates the need for separate dye injections in sentinel-guided surgery. Based on these advantageous properties, Superparamagnetic Iron Oxide Nanoparticle (SPION) have been successfully applied for marking and intraoperative detection of SLNs in breast cancer to overcome the drawbacks of the radioisotope-based sentinel procedure [12]
The study included 50 intermediate- or high-risk PCa patients who underwent radical retropubic prostatectomy with magnetometer-guided sentinel LN dissection (sLND) after intraprostatic injection of SPIONs, with eLND being performed as the reference standard
Summary
Histopathological examination or pelvic lymph node (LN) dissection (LND) is still the gold standard for LN staging in clinically localized prostate cancer (PCa). Cancers 2020, 12, 32 the extent of LND directly influence the rate of detected LN-positive patients [1]. Complications arise along with the number of LNs removed [2]. LND (eLND), as well as the low detection rate of limited LND methods, the concept of targeted radioisotope-guided sentinel LN (SLN) identification used in other tumor entities was implemented in PCa [3]. Marking of SLNs with technetium-99m (99m Tc) nanocolloid and a gamma probe for intraoperative SLN detection are used for the established radioisotope-guided SLN identification in PCa patients. In sentinel cohorts, targeted sLND detected a higher rate of LN-positive patients than were expected from established nomograms [5,6,7]
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