Evidence map›Paper›PMID 40595556›Full record

ArticleNature communications2025

Intraoperative nerve-specific fluorescence visualization in head and neck surgery: a Phase 1 trial.

Yu-Jin Lee, Ryan K Orosco, Michael Bouvet, Jeremy D Richmon, Brett J Berman, Kayva L Crawford, Marisa Hom, Quyen T Nguyen, Eben L Rosenthal

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04420689 (Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–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.

NCT04420689 phase1 / phase2completednot on this map

Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery

TypeinterventionalSponsorAlume Biosciences, Inc.Ran2020 to 2022Enrolled27ConditionsParotid Neoplasm, Thyroid Neoplasms, Head and Neck Neoplasms, SurgeryArmsBevonescein
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Translation of Intraoperative Molecular Imaging for Clinical Use.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. 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

9 authors.

Yu-Jin Lee *Department of Otolaryngology-Head and Neck Surgery, Stanford University, Palo Alto, CA, USA.
Ryan K Orosco *Department of Surgery, Division of Otolaryngology-Head and Neck Surgery, University of New Mexico, Albuquerque, NM, USA.
Michael BouvetDepartment of Surgery, University of California, San Diego, La Jolla, CA, USA.
Jeremy D RichmonDepartment of Otolaryngology-Head and Neck Surgery, Mass Eye and Ear, Harvard Medical School, Boston, MA, USA.
Brett J BermanAlume Biosciences, San Diego, CA, USA.
Kayva L CrawfordDepartment of Otolaryngology-Head and Neck Surgery, University of California, San Diego, La Jolla, CA, USA.
Marisa HomDepartment of Otolaryngology-Head and Neck Surgery, Vanderbilt University, Nashville, TN, USA.
Quyen T NguyenAlume Biosciences, San Diego, CA, USA.
Eben L RosenthalDepartment of Otolaryngology-Head and Neck Surgery, Vanderbilt University, Nashville, TN, USA. e.rosenthal@vumc.org.ORCID http://orcid.org/0000-0003-0294-5203

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Iatrogenic nerve injury is a surgical complication with significant morbidity. This clinical trial, now complete, investigates the systemic administration of bevonescein, which selectively binds to nerves, in a single-arm, prospective multi-center, dose-escalation Phase 1 trial in adult patients with head and neck neoplasms undergoing parotidectomy or thyroidectomy in the United States. Twenty-seven participants are enrolled in the trial and receive the systemic agent. The primary outcome is safety with no dose-limiting toxicity among the 27 patients, but a single adverse event was identified that was possibly related to the study drug (vomiting). Secondary outcomes include the pharmacokinetics, optimal dose, and timing of bevonescein. The half-life of bevonescein is 29-72 min, and the optimal dose is 500 mg by objective measures, with the fluorescence signal-to-background ratio (SBR; 2.1 ± 0.8) significantly higher compared to white light (1.3 ± 0.2; p = 0.003). The fluorescent SBR of nerves between the early (1-3 h) versus late (3-5 h) timing cohorts is not statistically different. Here, we present data of a nerve imaging agent showing that preoperative intravenous infusion of bevonescein is well tolerated. This trial is registered at ClinicalTrials.gov (NCT04420689) and is sponsored by Alume Biosciences (San Diego, CA).

Indexed as

Head and Neck NeoplasmsOptical ImagingAdultAgedFemaleFluorescenceHumansMaleMiddle AgedParotid GlandProspective StudiesThyroidectomy

Identifiers

PMID40595556
PMCPMC12219357

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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.