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Purpose: Currently, approximately 11–38% of prostate cancer (PCa) patients undergoing radical prostatectomy have a positive surgical margin (PSM) on histopathology. Cerenkov luminescence imaging (CLI) using 68Ga-prostate-specific membrane antigen (68Ga-PSMA) is a novel technique for intraoperative margin assessment. The aim of this first-in-man study was to investigate the feasibility of intraoperative 68Ga-PSMA CLI. In this study, feasibility was defined as the ability to distinguish between a positive and negative surgical margin, imaging within 45 min and low radiation exposure to staff. Methods: Six patients were included in this ongoing study. Following perioperative i.v. injection of ~ 100 MBq 68Ga-PSMA, the prostate was excised and immediately imaged ex vivo. Different acquisition protocols were tested, and hotspots on CLI images from the intact prostate were marked for comparison with histopathology. Results: By using an acquisition protocol with 150 s exposure time, 8 × 8 binning and a 550 nm shortpass filter, PSMs and negative surgical margins (NSMs) were visually correctly identified on CLI in 3 of the 5 patients. Two patients had a hotspot on CLI from cancer < 0.1 mm from the excision margin. Conclusion: Overall, the study showed that 68Ga-PSMA CLI is a feasible and low-risk technique for intraoperative margin assessment in PCa. The remaining patients in this ongoing study will be used to assess the diagnostic accuracy of the technique. Trial registration: NL8256 registered at www.trialregister.nl on 04/11/20109. [ABSTRACT FROM AUTHOR]

Cerenkov luminescence imaging (CLI) is a novel imaging technology that might have the ability to assess surgical margins intraoperatively during prostatectomy using 68 Ga-prostate-specific membrane antigen ( 68 Ga-PSMA-11). This study evaluated the accuracy of CLI compared with histopathology and, as an exploratory objective, investigated the characteristics of the identified chemiluminescence signal. Methods: After intravenous injection of a mean 68 Ga-PSMA-11 activity of 69 MBq intraoperatively, all excised specimens were imaged with CLI. Areas of increased signal were marked for histopathologic comparison and scored for the likelihood of being a positive surgical margin (PSM) using a 5-point Likert scale. In addition, the chemiluminescence signal was investigated in 3 radioactive and 3 nonradioactive specimens using CLI. Results: In 15 patients, the agreement between CLI and histopathology was 60%; this improved to 83% when including close surgical margins (≤1 mm). In 6 hot spots, CLI correctly identified PSMs on histopathology, located at the apex and mid prostate. In all 15 patients, an increased signal at the prostate base was observed, without the presence of the primary tumor in this area in 8 patients. This chemiluminescence signal was also observed in nonradioactive prostate specimens, with a half-life of 48 ± 11 min. The chemiluminescence hampered the visual interpretation of 4 PSMs at the base. Conclusion: CLI was able to correctly identify margin status, including close margins, in 83% of the cases. The presence of a diathermy-induced chemiluminescent signal hampered image interpretation, especially at the base of the prostate. In the current form, CLI is most applicable to detect PSMs and close margins in the apex and mid prostate., (© 2022 by the Society of Nuclear Medicine and Molecular Imaging.)

The challenge in delineating the boundary between cancerous and healthy tissue during cancer resection surgeries can be addressed with the use of intraoperative probes to detect cancer cells labeled with radiotracers to facilitate excision. In this study, deep learning algorithms for background gamma ray signal rejection were explored for an intraoperative probe utilizing CMOS monolithic active pixel sensors optimized toward the detection of internal conversion electrons from [Formula: see text]Tc. Two methods utilizing convolutional neural networks (CNNs) were explored for beta-gamma discrimination: 1) classification of event clusters isolated from the sensor array outputs (SAOs) from the probe and 2) semantic segmentation of event clusters within an acquisition frame of an SAO which provides spatial information on the classification. The feasibility of the methods in this study was explored with several radionuclides including 14 C, 57 Co, and [Formula: see text]Tc. Overall, the classification deep network is able to achieve an improved area under the curve (AUC) of the receiver operating characteristic (ROC), giving 0.93 for 14 C beta and [Formula: see text]Tc gamma clusters, compared to 0.88 for a more conventional feature-based discriminator. Further optimization of the lower left region of the ROC by using a customized AUC loss function during training led to an improvement of 31% in sensitivity at low false positive rates compared to the conventional method. The segmentation deep network is able to achieve a mean dice score of 0.93. Through the direct comparison of all methods, the classification method was found to have a better performance in terms of the AUC.

Purpose: Currently, approximately 11-38% of prostate cancer (PCa) patients undergoing radical prostatectomy have a positive surgical margin (PSM) on histopathology. Cerenkov luminescence imaging (CLI) using 68 Ga-prostate-specific membrane antigen ( 68 Ga-PSMA) is a novel technique for intraoperative margin assessment. The aim of this first-in-man study was to investigate the feasibility of intraoperative 68 Ga-PSMA CLI. In this study, feasibility was defined as the ability to distinguish between a positive and negative surgical margin, imaging within 45 min and low radiation exposure to staff., Methods: Six patients were included in this ongoing study. Following perioperative i.v. injection of ~ 100 MBq 68 Ga-PSMA, the prostate was excised and immediately imaged ex vivo. Different acquisition protocols were tested, and hotspots on CLI images from the intact prostate were marked for comparison with histopathology., Results: By using an acquisition protocol with 150 s exposure time, 8 × 8 binning and a 550 nm shortpass filter, PSMs and negative surgical margins (NSMs) were visually correctly identified on CLI in 3 of the 5 patients. Two patients had a hotspot on CLI from cancer < 0.1 mm from the excision margin., Conclusion: Overall, the study showed that 68 Ga-PSMA CLI is a feasible and low-risk technique for intraoperative margin assessment in PCa. The remaining patients in this ongoing study will be used to assess the diagnostic accuracy of the technique., Trial Registration: NL8256 registered at www.trialregister.nl on 04/11/20109.

In early-stage breast cancer, the primary treatment option for most women is breast-conserving surgery (BCS). There is a clear need for more accurate techniques to assess resection margins intraoperatively, because on average 20% of patients require further surgery to achieve clear margins. Cerenkov luminescence imaging (CLI) combines optical and molecular imaging by detecting light emitted by 18 F-FDG. Its high-resolution and small size imaging equipment make CLI a promising technology for intraoperative margin assessment. A first-in-human study was conducted to evaluate the feasibility of 18 F-FDG CLI for intraoperative assessment of tumor margins in BCS. Methods: Twenty-two patients with invasive breast cancer received 18 F-FDG (5 MBq/kg) 45-60 min before surgery. Sentinel lymph node biopsy was performed using an increased 99m Tc-nanocolloid activity of 150 MBq to facilitate nodal detection against the γ-probe background signal (cross-talk) from 18 F-FDG. The cross-talk and 99m Tc dose required was evaluated in 2 lead-in studies. Immediately after excision, specimens were imaged intraoperatively in an investigational CLI system. The first 10 patients were used to optimize the imaging protocol; the remaining 12 patients were included in the analysis dataset. Cerenkov luminescence images from incised BCS specimens were analyzed postoperatively by 2 surgeons blinded to the histopathology results, and mean radiance and margin distance were measured. The agreement between margin distance on CLI and histopathology was assessed. Radiation doses to staff were measured. Results: Ten of the 12 patients had an elevated tumor radiance on CLI. Mean radiance and tumor-to-background ratio were 560 ± 160 photons/s/cm 2 /sr and 2.41 ± 0.54, respectively. All 15 assessable margins were clear on CLI and histopathology. The agreement in margin distance and interrater agreement was good (κ = 0.81 and 0.912, respectively). Sentinel lymph nodes were successfully detected in all patients. The radiation dose to staff was low; surgeons received a mean dose of 34 ± 15 μSv per procedure. Conclusion: Intraoperative 18 F-FDG CLI is a promising, low-risk technique for intraoperative assessment of tumor margins in BCS. A randomized controlled trial will evaluate the impact of this technique on reexcision rates., (© 2017 by the Society of Nuclear Medicine and Molecular Imaging.)