Evidence map›Paper›PMID 30555550›Full record

ReviewTheranostics2018

Recommendations for reporting on emerging optical imaging agents to promote clinical approval.

Willemieke S Tummers, Jason M Warram, Nynke S van den Berg, Sarah E Miller, Rutger-Jan Swijnenburg, Alexander L Vahrmeijer, Eben L Rosenthal

Abstract readReview
In one paragraph

Review in Theranostics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Targeted Fluorescence Imaging of Bevacizumab-800CW in Patients with Neovascular Age-Related Macular Degeneration.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Trial
  4. Interim Phase II Results Using Panitumumab-IRDye800CW during Transoral Robotic Surgery in Patients with Oropharyngeal Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Trial
  5. Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Article
  13. Evaluation of a targeted anti-αEuropean journal of nuclear medicine and molecular imaging · 2025
    Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Review
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

7 authors.

Willemieke S TummersDepartment of Radiology, Molecular Imaging Program, Stanford University, Stanford, CA.
Jason M WarramDepartment of Otolaryngology, University of Alabama at Birmingham, AL.
Nynke S van den BergDepartment of Otolaryngology, Stanford University, Stanford, CA.
Sarah E MillerDepartment of Otolaryngology, Stanford University, Stanford, CA.
Rutger-Jan SwijnenburgDepartment of Surgery, Leiden University Medical Center, Leiden, Netherlands.
Alexander L VahrmeijerDepartment of Surgery, Leiden University Medical Center, Leiden, Netherlands.
Eben L RosenthalDepartment of Otolaryngology, Stanford University, Stanford, CA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Intraoperative fluorescence imaging is particularly well-suited for surgical applications due to its inherently high sensitivity, resolution, and ability to provide images in real-time. To date, the intraoperative observation of fluorescence has largely been subjective. With the need to show objective evidence in order to demonstrate the benefit of this technique, quantitative data needs to be provided to overseeing regulatory bodies. Standardization of fluorescence imaging protocols would improve reproducibility and minimize inter- and intra-institution variance. This would allow studies to be conducted using the same injection techniques, imaging times, reconstruction methods, and analyses. Here, we provide recommendations for standardized methodologies with the goal of setting a minimum requirement for reporting fluorescence-guided surgery results based on both qualitative and (semi-) quantitative data collection. Clinical trials using fluorescence-guided surgery should present results of three critical elements; 1) intra-operative imaging, 2) specimen mapping and pathology correlation, and 3) target validation. Qualitative analyses should consist of a bright field image, black-and-white fluorescence image, pseudo-colored fluorescence overlay image, and/or heat-map whereby fluorescence signal intensity differences are displayed on a color spectrum. Quantitative analyses should include 1) intraoperative data (consisting of images or video, raw numeric values and ratios); 2) specimen mapping, for correlation of fluorescence with the presence of disease (performed using fresh tissue); and 3) target validation (designed to determine fluorescence intensity relative to receptor density of a specific area). Including the aforementioned methods of both qualitative and quantitative analyses will ensure that trial results are comparable and could be collated in future studies to expedite FDA approval.

Indexed as

Clinical Trials as TopicDrug ApprovalHumansMolecular ImagingOptical ImagingSurgery, Computer-Assistedclinical trialfluorescenceOptical imagingresult reportingstandardization

Identifiers

PMID30555550
PMCPMC6276089

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.