Integration and evaluation of a gradient-based needle navigation system for percutaneous MR-guided interventions

Li Pan; Steffi Valdeig; Urte Kägebein; Kun Qing; Barry Fetics; Amir Roth; Erez Nevo; Bennet Hensen; Clifford R. Weiss; Frank K. Wacker

doi:10.1371/journal.pone.0236295

Peer Review History

Original SubmissionMarch 11, 2020
26 May 2020 Decision Letter - Zhongliang Zu, Editor PONE-D-20-07053 Integration and Evaluation of a Gradient-based Needle Navigation System for Percutaneous MR-guided Interventions PLOS ONE Dear Dr. Hensen, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Jul 10 2020 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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Thank you for stating the following in the Competing Interests section: "I have read the journal's policy and the authors of this manuscript have the following competing interests:Li Pan = full employee of Siemens Healthineers; Kun Qing = receives grant support from Siemens Healthineers and was an intern employee while working on this Project; Barry Fetics/Amir Roth = employee of Robin Medical; Erez Nevo = founder and stock owner in Robin Medical; Clifford Weiss = receives grant support from Siemens Healthineers, for BTG and Medtronic, is a consultant for BTG and Medtronic; Frank Wacker = receives institutional funding from Siemens" We note that one or more of the authors are employed by a commercial company: Siemens Healthineers, Robin Medical, BTG and Medtronic 1. Please provide an amended Funding Statement declaring this commercial affiliation, as well as a statement regarding the Role of Funders in your study. 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Please follow the link for more information: https://blogs.plos.org/plos/2019/06/looking-good-tips-for-creating-your-plos-figures-graphics/ [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Partly Reviewer #3: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A Reviewer #2: Yes Reviewer #3: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: This is an interesting paper. The following points should be considered to further improve it. 1. Figures 1, 3, 4 are very low resolution. Please replace with high DPI version. 2. The results describe the performance of the proposed system but no control group was presented. The Authors should at least provide a comparison based on the literature (e.g. needle insertion time, error in plane and in 3D for competitor solutions). 3. The Authirs write on Page 21 "The multi-slice real-time images were acquired and displayed in a mosaic mode to enable device guidance while allowing the operator to adapt to both organ movement due to breathing and tissue deformation/displacement due to needle insertion." Later however the Authors write (on Page 23) "we targeted only organs that have minimal motion during breathing". Please explain the reason for this choice, since the system should be able to cope with this, right? 4. On page 23 the Authors write "we observed overshooting of the needle in both, phantom and animal experiments". A relatively simple solution to this problem would be a depth gauge on the needle. Is this not possible with the proposed system? Reviewer #2: The manuscript is interesting and well written. I can see the interest of the system but do the results really support that this helps the IR? not sure (8mm deviation, 4 cases of overshooting)... it is not an issue as it is work in progress, but this should be mentioned in the discussion especially Given the conflict of interests of the authors, A couple of points that need to be addressed/corrected to my point of view: - is the needle holder sterilizable? - please provide the characteristics of the BEAT-IRTTT sequences - line 168: in which plane were HASTE images acquired? was was the number of HASTE images? - fig7 is mentioned before fig6 in the text - line 223: what were the reasons to use a T1 or a T2 sequence? please be more precise - what were the targets in the pigs? Kidney is rather vague. Same for cervical spine or shoulder. a figure could be helpful - results section and measures: given the low spatial resolution of MRI guidance, giving a hundredth of millimeter does not make sense. there is a huge place for errors there. Who made the measurements? how many times were they made? - line 282 to 295: you give a lot of measures but the terms are unclear. It would be better to specify clearly which results apply to expriement1/2 and IR1/2 - was overshooting recognized at the time of puncture? if not, i believe that statistic should be presented including the outlier target. - line 291: learning curve: how do you compare the learning curve? it was not specified in the method section. Moreover, base on the length of procedure, it seems to be a difference - please provide a p-value if there is one to compare precision and time to insert the needle between IR1 and IR2 - line 299 to 305: these are not results. It is a subjective description, please remove Reviewer #3: This study aimed to investigate the feasibility, accuracy and clinical implementation with use of an animal model of a grading-based navigation system for MR guided interventions using an open bore 1.5 Tesla MRI system. This is a timely topic as interventional MRI procedures gain traction and thus navigation systems are important and will become even more important in the future. The navigation system is well described. The methods and statistical analysis are described in detail and to my review appropriate. The manuscript is very well written, without major requirements for edits. The figures and illustrations are excellent. The manuscript includes detailed information for readers to implement and reproduce the techniques that result of this study, respectively. The author group is well known to the field of interventional magnetic resonance imaging including several pioneers and clinically active interventional radiologists, which carries a high credibility for the study. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No Reviewer #3: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. 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Revision 1
16 Jun 2020 Author Response Dear Dr. Zu, I would like to thank you and your reviewers for the time and effort you have put into the review of our manuscript. We really appreciate all of your input. The following is a detailed summary of the replies and changes made in our manuscript in direct response to each specific reviewer comment. Sincerely, Bennet Hensen and Frank Wacker, for all authors Journal requirements: 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at http://www.plosone.org/attachments/PLOSOne_formatting_sample_main_body.pdf and http://www.plosone.org/attachments/PLOSOne_formatting_sample_title_authors_affiliations.pdf The manuscript style was adapted to the style requirements. 2. Please include the following information in your methods section: • Please specify the source from which animals were obtained • Please provide details of animal welfare and housing (e.g., shelter, food, water, environmental enrichment) • Please complete and submit a copy of the ARRIVE Guidelines checklist, a document that aims to improve experimental reporting and reproducibility of animal studies for purposes of post-publication data analysis and reproducibility: https://www.nc3rs.org.uk/arrive-guidelines. Please include your completed checklist as a Supporting Information file. Note that if your paper is accepted for publication, this checklist will be published as part of your article. Detailed information on animal source and animal welfare and housing was added. The ARRIVE Guidelines checklist was uploaded. 3. Thank you for stating the following in the Competing Interests section: (…) An updated Funding Statement and a Competing Interests Statement was included in the cover letter. 4. PLOS requires an ORCID iD for the corresponding author in Editorial Manager on papers submitted after December 6th, 2016. The ORCID iD was added. 5. Please upload a new copy of Figure 4 as the detail is not clear. Please follow the link for more information: https://blogs.plos.org/plos/2019/06/looking-good-tips-for-creating-your-plos-figures-graphics/ All Figures are now replaced with high DPI versions. Figure 4 has been adjusted and homogenized, the sequence diagrams now look the same. Review Comments to the Author: Reviewer #1: This is an interesting paper. The following points should be considered to further improve it. 1. Figures 1, 3, 4 are very low resolution. Please replace with high DPI version. All Figures are now replaced with high DPI versions. 2. The results describe the performance of the proposed system, but no control group was presented. The Authors should at least provide a comparison based on the literature (e.g. needle insertion time, error in plane and in 3D for competitor solutions). We included a comparison based on the literature in the “Discussion” section (line 533 – 536). 3. The Authors write on Page 21 "The multi-slice real-time images were acquired and displayed in a mosaic mode to enable device guidance while allowing the operator to adapt to both organ movement due to breathing and tissue deformation/displacement due to needle insertion." Later however the Authors write (on Page 23) "we targeted only organs that have minimal motion during breathing". Please explain the reason for this choice, since the system should be able to cope with this, right? The current system includes static as well as real time information. This is now explained in the “Discussion” section (line 587 – 592). 4. On page 23 the Authors write "we observed overshooting of the needle in both, phantom and animal experiments". A relatively simple solution to this problem would be a depth gauge on the needle. Is this not possible with the proposed system? We agree with the reviewer that a depth gauge could be a simple solution. However, elasticity of soft tissue in humans, animals and most phantoms cause pushback once the target is reached. In order to adjust for elastic resistance, overshooting is somewhat intended but the extent is sometimes difficult to foresee, especially when relying on needle tip visualization in static rather than realtime images. Reviewer #2: The manuscript is interesting and well written. I can see the interest of the system but do the results really support that this helps the IR? not sure (8mm deviation, 4 cases of overshooting)... it is not an issue as it is work in progress, but this should be mentioned in the discussion especially Given the conflict of interests of the authors, We agree with the reviewer. This is a prototype system not ready for clinical use. We clarified this in the “Discussion” section (line 613 – 617). A couple of points that need to be addressed/corrected to my point of view: - is the needle holder sterilizable? Yes, this information were added in the manuscript (line 113) - please provide the characteristics of the BEAT-IRTTT sequences Details for BEAT-IRTTT were added in the methods section (line 161 - 164) - line 168: in which plane were HASTE images acquired? What was the number of HASTE images? The HASTE sequence was acquired in an axial, coronal and transversal plane (line 187). - fig7 is mentioned before fig6 in the text This was corrected. - line 223: what were the reasons to use a T1 or a T2 sequence? please be more precise T1 images were selected. This information has been corrected in the manuscript. - what were the targets in the pigs? Kidney is rather vague. Same for cervical spine or shoulder. a figure could be helpful Spine: the cervical intervertebral foramen to simulate a transforaminal epidural injection Shoulder joint: the anterior edge of the glenoid to simulate an anterior approach to shoulder arthrography Kidney: minor calyx of the lower pole to simulate a nephrostomy Details are now given in the manuscript (line 298-300) - results section and measures: given the low spatial resolution of MRI guidance, giving a hundredth of millimeter does not make sense. there is a huge place for errors there. Who made the measurements? how many times were they made? We fully agree with the reviewer, that this does not make sense. Therefore, the numbers were rounded. - line 282 to 295: you give a lot of measures but the terms are unclear. It would be better to specify clearly which results apply to expriement1/2 and IR1/2 In the “Results” section, the measurements are given for experiment 1 and 2 and for IR 1 and 2 respectively. We clarified this by adding some information regarding IR 1 and 2. - was overshooting recognized at the time of puncture? if not, i believe that statistic should be presented including the outlier target. Overshooting was recognized during the intervention by the less experienced radiologist who overestimated elasticity and prematurely finished the respective puncture. For full disclosure the experiments are mentioned but, give the operator error, are not included in the results. - line 291: learning curve: how do you compare the learning curve? it was not specified in the method section. Moreover, base on the length of procedure, it seems to be a difference An operator not familiar with a guidance system usually improves after the first set of experiments. In order to account for a potential learning curve, we therefore compared experiment 1 and 2 for both IR1 and 2. This was clarified in the “Results” section. - please provide a p-value if there is one to compare precision and time to insert the needle between IR1 and IR2 This information is given in the “Results” section (time to insert: line 463; precision: line 456). - line 299 to 305: these are not results. It is a subjective description, please remove We agree. The paragraph is omitted. Attachments Attachment Submitted filename: Response_to_Reviewers.docx https://doi.org/10.1371/journal.pone.0236295.r002
6 Jul 2020 Decision Letter - Zhongliang Zu, Editor Integration and Evaluation of a Gradient-based Needle Navigation System for Percutaneous MR-guided Interventions PONE-D-20-07053R1 Dear Dr. Hensen, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Zhongliang Zu, Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The Authors have addressed all comments from this reviewer. In my opinion, the manuscript is ready for publication. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No https://doi.org/10.1371/journal.pone.0236295.r003
Formally Accepted
8 Jul 2020 Acceptance Letter - Zhongliang Zu, Editor PONE-D-20-07053R1 Integration and Evaluation of a Gradient-based Needle Navigation System for Percutaneous MR-guided Interventions Dear Dr. Hensen: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Zhongliang Zu Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0236295.r004

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