Evidence map›Paper›PMID 29623552›Full record

Trial reportJournal of neuro-oncology2018

First-in-human intraoperative near-infrared fluorescence imaging of glioblastoma using cetuximab-IRDye800.

Sarah E Miller, Willemieke S Tummers, Nutte Teraphongphom, Nynke S van den Berg, Alifia Hasan, Robert D Ertsey, Seema Nagpal, Lawrence D Recht, Edward D Plowey, Hannes Vogel and 4 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04161560 (Cetuximab - IRDye800 Intraoperative Fluorescence Imaging in Esophagectomy of Esophageal Cancer), which is not on this map. Cited by 103 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
103citing papers in PubMed, 2 pooled it
8.7field-weighted citation impact, top 2% 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.

NCT04161560 phase1unknown statusnot on this mapstarted 2019, after this paper: background citation

Cetuximab - IRDye800 Intraoperative Fluorescence Imaging in Esophagectomy of Esophageal Cancer:A Single Center Clinical Research

TypeinterventionalSponsorFifth Affiliated Hospital, Sun Yat-Sen UniversityRan2019 to 2021Enrolled40ConditionsDrug Safety, Drug SpecificityArmsCetuximab-IRDye800
3 · Its place in the literature

Who cites it

103 citing papers in PubMed, 2 syntheses or guidelines pooled it, 163 citations in OpenAlex.

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43 more citing papers are in PubMed but not listed here.

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

14 authors at 3 institutions in 2 countries.

Sarah E MillerDepartment of Otolaryngology, Stanford University, Stanford, USA.
Willemieke S TummersDepartment of Radiology, Molecular Imaging Program at Stanford (MIPS), Stanford University, Stanford, USA.
Nutte TeraphongphomDepartment of Otolaryngology, Stanford University, Stanford, USA.
Nynke S van den BergDepartment of Otolaryngology, Stanford University, Stanford, USA.
Alifia HasanDepartment of Otolaryngology, Stanford University, Stanford, USA.
Robert D ErtseyDepartment of Otolaryngology, Stanford University, Stanford, USA.
Seema NagpalDepartment of Neurology, Stanford University, Stanford, USA.
Lawrence D RechtDepartment of Neurology, Stanford University, Stanford, USA.
Edward D PloweyDepartment of Pathology, Stanford University, Stanford, USA.
Hannes VogelDepartment of Pathology, Stanford University, Stanford, USA.
Griffith R HarshDepartment of Neurosurgery, Stanford University, Stanford, CA, 94305, USA.
Gerald A GrantDepartment of Neurosurgery, Stanford University, Stanford, CA, 94305, USA.
Gordon H LiDepartment of Neurosurgery, Stanford University, Stanford, CA, 94305, USA.
Eben L RosenthalDepartment of Otolaryngology, Stanford University, Stanford, USA. elr@stanford.edu.ORCID http://orcid.org/0000-0003-0294-5203
Stanford University · USLeiden University Medical Center · NLStanford Medicine · US

Funding

Prototype optical device for image guided surgery with panitumumab-IRDye800R01CA190306 · NCI · STANFORD UNIVERSITY · PI ROSENTHAL, EBEN L. · 2015 to 2019
$2.6M
NMDA receptor trafficking by the autophagy regulatory protein beclin 1K08NS085324 · NINDS · STANFORD UNIVERSITY · PI PLOWEY, EDWARD D · 2014 to 2017
$717k
NCI NIH HHS R01 CA190306NIH HHS R01CA190306NINDS NIH HHS K08 NS085324
6 · The paper itself

Abstract

introductionMaximizing extent of surgical resection with the least morbidity remains critical for survival in glioblastoma patients, and we hypothesize that it can be improved by enhancements in intraoperative tumor detection. In a clinical study, we determined if therapeutic antibodies could be repurposed for intraoperative imaging during resection.

methodsFluorescently labeled cetuximab-IRDye800 was systemically administered to three patients 2 days prior to surgery. Near-infrared fluorescence imaging of tumor and histologically negative peri-tumoral tissue was performed intraoperatively and ex vivo. Fluorescence was measured as mean fluorescence intensity (MFI), and tumor-to-background ratios (TBRs) were calculated by comparing MFIs of tumor and histologically uninvolved tissue.

resultsThe mean TBR was significantly higher in tumor tissue of contrast-enhancing (CE) tumors on preoperative imaging (4.0 ± 0.5) compared to non-CE tumors (1.2 ± 0.3; p = 0.02). The TBR was higher at a 100 mg dose than at 50 mg (4.3 vs. 3.6). The smallest detectable tumor volume in a closed-field setting was 70 mg with 50 mg of dye and 10 mg with 100 mg. On sections of paraffin embedded tissues, fluorescence positively correlated with histological evidence of tumor. Sensitivity and specificity of tumor fluorescence for viable tumor detection was calculated and fluorescence was found to be highly sensitive (73.0% for 50 mg dose, 98.2% for 100 mg dose) and specific (66.3% for 50 mg dose, 69.8% for 100 mg dose) for viable tumor tissue in CE tumors while normal peri-tumoral tissue showed minimal fluorescence.

conclusionThis first-in-human study demonstrates the feasibility and safety of antibody based imaging for CE glioblastomas.

Indexed as

Optical ImagingSurgery, Computer-AssistedAntineoplastic Agents, ImmunologicalBrainBrain NeoplasmsCetuximabDose-Response Relationship, DrugFluorescent DyesGlioblastomaHumansIndolesSensitivity and SpecificitySpectroscopy, Near-InfraredAntineoplastic Agents, ImmunologicalCetuximabFluorescent DyesIndolesIRDye800Antibody-based imagingBrain neoplasmsCetuximabFluorescenceGlioblastomaImage-guided surgeryPhase 1

Identifiers

PMID29623552
PMCPMC6031450
OpenAlexW2795715780

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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.