Confocal Laser Endomicroscopy and Optical Coherence Tomography for the Diagnosis of Prostate Cancer: A Needle-Based, In Vivo Feasibility Study Protocol (IDEAL Phase 2A)

Swaan, Abel; Mannaerts, Christophe K.; Scheltema, Matthijs J.; Nieuwenhuijzen, Jakko A.; Savcı-Heijink, C. Dilara; Rosette, Jean J.M.C.H. de la; Moorselaar, R. Jeroen A. van; Leeuwen, Ton G. van; Reijke, Theo M. de; Bruin, Daniël M. de

doi:10.2196/resprot.9813

Cited by 9 publications

(10 citation statements)

References 42 publications

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Section: Resultsmentioning

confidence: 99%

“…Initial screening identified 62 of 136 records (45·6 per cent) for full‐text eligibility assessment. Finally, 48 relevant publications (42 study reports, 6 protocols) were included in the analysis 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 ( Fig . 1 ).…”

Section: Resultsmentioning

confidence: 99%

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Outcome selection, measurement and reporting for new surgical procedures and devices: a systematic review of IDEAL/IDEAL-D studies to inform development of a core outcome set

et al. 2020

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Background: Outcome selection, measurement and reporting for the evaluation of new surgical procedures and devices is inconsistent and lacks standardization. A core outcome set may promote the safe and transparent evaluation of surgical innovations. This systematic review examined outcome selection, measurement and reporting in studies conducted within the IDEAL (Idea, Development, Exploration, Assessment and Long-term monitoring) framework to examine current practice and inform the development of a core outcome set for early-phase studies of surgical procedures/devices. Methods: Web of Science and Scopus citation searches were performed to identify author-reported IDEAL/IDEAL-D studies for any surgical procedure/device. Outcomes were extracted verbatim, including contextual information regarding outcome selection and measurement. Outcomes were categorized to inform a conceptual framework of outcome domains relevant to evaluating innovation. Results: Some 48 studies were identified. Outcome selection, measurement and reporting varied widely across studies in different IDEAL stages. From 1737 outcomes extracted, 22 domains specific to evaluating innovation were conceptualized under seven broad categories: procedure completion success/failure; modifications; unanticipated events; surgeons' experiences; patients' experiences; resource use specific to the innovative procedure/device; and other innovation-specific outcomes. Most innovation-specific outcomes were measured and reported in only a small number of studies. Conclusion: This review highlighted the need for guidance and standardization in outcome selection and reporting in the evaluation of new surgical procedures/devices. Novel outcome domains specific to innovation have been identified to establish a core outcome set for future evaluations of surgical innovations.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Outcome selection, measurement and reporting for new surgical procedures and devices: a systematic review of IDEAL/IDEAL-D studies to inform development of a core outcome set

et al. 2020

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“…Recently, an ex vivo OCT image atlas has been developed for the prostate based on a nearperfect registration with histology [12]. Based on these results, a protocol has been developed to test needle-based OCT in vivo in the prostate [13]. In this study, we demonstrate, for the first time to our knowledge, the safety and feasibility of in vivo needle-based OCT imaging of the prostate.…”

Section: Introductionmentioning

confidence: 87%

“…This study is an investigator‐initiated, prospective in vivo feasibility study, approved by the local institutional review board under registry number: NL57326.018.17. The study is registered on clinicaltrails.gov as Focal Prostate Imaging with CLE and OCT (FPI) (NCT03253458) on August 18, 2017, and the full trial protocol has been previously published .…”

Section: Methodsmentioning

confidence: 99%

“…[12,23,24] The possibility of collecting good quality images of the prostate with needle-based OCT measurements is now the first successful step towards a larger cohort study that aims to correlate OCT with histology to set up in vivo discriminative parameters. [13] By using two highly selected patients with PCa prior to this proposed correlation study, we follow the IDEAL recommendations [25]. Distinguishing some tissue types with OCT is possible.…”

Section: Comparing In Vivo Oct With Previously Published Atlasmentioning

confidence: 99%

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The First In Vivo Needle‐Based Optical Coherence Tomography in Human Prostate: A Safety and Feasibility Study

et al. 2019

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Objective To demonstrate the safety and feasibility of clinical in vivo needle‐based optical coherence tomography (OCT) imaging of the prostate. Materials and Methods Two patients with prostate cancer underwent each two percutaneous in vivo needle‐based OCT measurements before transperineal template mapping biopsy. The OCT probe was introduced via a needle and positioned under ultrasound guidance. To test the safety, adverse events were recorded during and after the procedure. To test the feasibility, OCT and US images were studied during and after the procedure. Corresponding regions for OCT and biopsy were determined. A uropathologist evaluated and annotated the histopathology. Three experts assessed all the corresponding OCT images. The OCT and biopsy conclusions for the corresponding regions were compared. Results No adverse events during and following the, in total four, in vivo needle‐based OCT measurements were reported. The OCT measurements showed images of prostatic tissue with a penetration depth of ~1.5 mm. The histological‐proven tissue types, which were also found in the overlapping OCT images, were benign glands, stroma, glandular atrophy, and adenocarcinoma (Gleason pattern 3). Conclusions Clinical in vivo needle‐based OCT of the prostate is feasible with no adverse events during measurements. OCT images displayed detailed prostatic tissue with a imaging depth up to ~1.5 mm. We could co‐register four histological‐proven tissue types with OCT images. The feasibility of in vivo OCT in the prostate opens the pathway to the next phase of needle‐based OCT studies in the prostate. Lasers Surg. Med. 51:390–398, 2019. © 2019 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

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