First-in-human validation of a DROP-IN β-probe for robotic radioguided surgery: defining optimal signal-to-background discrimination algorithm.

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...

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Publicado en:European Journal of Nuclear Medicine & Molecular Imaging Vol. 51; no. 10; pp. 3098 - 3109
Autores principales: 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
Formato: Journal Article
Publicado: Springer Nature Aug2024
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Aug2024
      vid: 51
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      pub: Springer Nature
      place: New York, New York
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        10.1007/s00259-024-06653-6
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        atl: First-in-human validation of a DROP-IN β-probe for robotic radioguided surgery: defining optimal signal-to-background discrimination algorithm.
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        au:
          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
        affil: https://ror.org/005ta0471 National Institute of Nuclear Physics (INFN), Section of Rome, Rome, Italy
      sug:
      ab: 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.
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
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