Evidence map›Paper›PMID 29784633›Full record

ArticleJMIR research protocols2018

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

Abel Swaan, Christophe K Mannaerts, Matthijs Jv Scheltema, Jakko A Nieuwenhuijzen, C Dilara Savci-Heijink, Jean Jmch de la Rosette, R Jeroen A van Moorselaar, Ton G van Leeuwen, Theo M de Reijke, Daniel Martijn de Bruin

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in JMIR research protocols, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03253458 (In-vivo Focal Prostate Imaging With Confocal Laser Endomicroscopy and Optical Coherence Tomography), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.1field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03253458 naunknown statusnot on this map

In-vivo Focal Prostate Imaging With Confocal Laser Endomicroscopy and Optical Coherence Tomography

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2018 to 2020Enrolled14ConditionsProstate CancerArmsConfocal Laser Endomicroscopy
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Image-guidedTechnology in cancer research & treatment
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 2 countries.

Abel SwaanDepartment of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0002-9945-3426
Christophe K MannaertsDepartment of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0002-3824-5631
Matthijs Jv ScheltemaDepartment of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0002-9098-9574
Jakko A NieuwenhuijzenDepartment of Urology, VU University Medical Center, VU University, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0002-8977-5501
C Dilara Savci-HeijinkDepartment of Pathology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0003-1220-0061
Jean Jmch de la RosetteAcademic Medical Center, University of Amsterdam, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0002-6308-1763
R Jeroen A van MoorselaarDepartment of Urology, VU University Medical Center, VU University, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0002-2559-9254
Ton G van LeeuwenDepartment of Biomedical Engineering and Physics, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0002-5642-1133
Theo M de ReijkeDepartment of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0003-0651-7361
Daniel Martijn de BruinDepartment of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.ORCID http://orcid.org/0000-0003-3047-3637
Amsterdam UMC Location University of Amsterdam · NLAmsterdam UMC Location Vrije Universiteit Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFocal therapy for prostate cancer has been proposed as an alternative treatment to whole-gland therapies in selected men to diminish side effects in localized prostate cancer. As nowadays imaging cannot offer complete prostate cancer disease characterization, multicore systematic biopsies are recommended (transrectal or transperineal). Optical imaging techniques such as confocal laser endomicroscopy and optical coherence tomography allow in vivo, high-resolution imaging. Moreover, they can provide real-time visualization and analysis of tissue and have the potential to offer additive diagnostic information.

objectiveThis study has 2 separate primary objectives. The first is to assess the technical feasibility and safety of in vivo focal imaging with confocal laser endomicroscopy and optical coherence tomography. The second is to identify and define characteristics of prostate cancer and normal prostate tissue in confocal laser endomicroscopy and optical coherence tomography imaging by comparing these images with the corresponding histopathology.

methodsIn this prospective, in vivo feasibility study, needle-based confocal laser endomicroscopy and optical coherence tomography imaging will be performed before transperineal template mapping biopsy or radical prostatectomy. First, confocal laser endomicroscopy and optical coherence tomography will be performed in 4 patients (2 for each imaging modality) undergoing transperineal template mapping biopsy to assess the feasibility and safety of confocal laser endomicroscopy and optical coherence tomography. If proven to be safe and feasible, confocal laser endomicroscopy and optical coherence tomography will be performed in 10 patients (5 for each imaging modality) undergoing radical prostatectomy. Confocal laser endomicroscopy and optical coherence tomography images will be analyzed by independent, blinded observers. Confocal laser endomicroscopy- and optical coherence tomography-based qualitative and quantitative characteristics and histopathology will be compared. The study complies with the IDEAL (Idea, Development, Exploration, Assessment, Long-term study) stage 2a recommendations.

resultsAt present, the study is enrolling patients and results and outcomes are expected in 2019.

conclusionsConfocal laser endomicroscopy and optical coherence tomography are promising optical imaging techniques that can visualize and analyze tissue structure, possible tumor grade, and architecture in real time. They can potentially provide real-time, high-resolution microscopic imaging and tissue characteristics of prostate cancer in conjunction with magnetic resonance imaging or transrectal ultrasound fusion-guided biopsy procedures. This study will provide insight into the feasibility and tissue-specific characteristics of confocal laser endomicroscopy and optical coherence tomography for real-time optical analysis of prostate cancer.

trial registrationClinicalTrials.gov NCT03253458; https://clinicaltrials.gov/ct2/show/NCT03253458 (Archived by WebCite at http://www.webcitation.org/6z9owM66B). REGISTERED REPORT IDENTIFIER: RR1-10.2196/9813.

Indexed as

confocal laser endomicroscopyhistologymicroscopyoptical coherence tomographyoptical imagingprostateprostatectomyprostatic neoplasms biopsy

Identifiers

PMID29784633
PMCPMC5987046
OpenAlexW2803831683

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.