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- Title
First-in-human validation of a DROP-IN β-probe for robotic radioguided surgery: defining optimal signal-to-background discrimination algorithm.
- Authors
Collamati, Francesco; Morganti, Silvio; van Oosterom, Matthias N.; Campana, Lorenzo; Ceci, Francesco; Luzzago, Stefano; Mancini-Terracciano, Carlo; Mirabelli, Riccardo; Musi, Gennaro; Nicolanti, Francesca; Orsi, Ilaria; van Leeuwen, Fijs W. B.; Faccini, Riccardo
- Abstract
Purpose: In radioguided surgery (RGS), radiopharmaceuticals are used to generate preoperative roadmaps (e.g., PET/CT) and to facilitate intraoperative tracing of tracer avid lesions. Within RGS, there is a push toward the use of receptor-targeted radiopharmaceuticals, a trend that also has to align with the surgical move toward minimal invasive robotic surgery. Building on our initial ex vivo evaluation, this study investigates the clinical translation of a DROP-IN β probe in robotic PSMA-guided prostate cancer surgery. Methods: A clinical-grade DROP-IN β probe was developed to support the detection of PET radioisotopes (e.g., 68 Ga). The prototype was evaluated in 7 primary prostate cancer patients, having at least 1 lymph node metastases visible on PSMA-PET. Patients were scheduled for radical prostatectomy combined with extended pelvic lymph node dissection. At the beginning of surgery, patients were injected with 1.1 MBq/kg of [68Ga]Ga-PSMA. The β probe was used to trace PSMA-expressing lymph nodes in vivo. To support intraoperative decision-making, a statistical software algorithm was defined and optimized on this dataset to help the surgeon discriminate between probe signals coming from tumors and healthy tissue. Results: The DROP-IN β probe helped provide the surgeon with autonomous and highly maneuverable tracer detection. A total of 66 samples (i.e., lymph node specimens) were analyzed in vivo, of which 31 (47%) were found to be malignant. After optimization of the signal cutoff algorithm, we found a probe detection rate of 78% of the PSMA-PET-positive samples, a sensitivity of 76%, and a specificity of 93%, as compared to pathologic evaluation. Conclusion: This study shows the first-in-human use of a DROP-IN β probe, supporting the integration of β radio guidance and robotic surgery. The achieved competitive sensitivity and specificity help open the world of robotic RGS to a whole new range of radiopharmaceuticals.
- Subjects
COMPUTER-assisted surgery; PROSTATE surgery; PROSTATE cancer patients; CANCER patients; LYMPHADENECTOMY
- Publication
European Journal of Nuclear Medicine & Molecular Imaging, 2024, Vol 51, Issue 10, p3098
- ISSN
1619-7070
- Publication type
Article
- DOI
10.1007/s00259-024-06653-6