Evidence map›Paper›PMID 32416764›Full record

ArticleThe lancet. Gastroenterology & hepatology2020

Tumour-specific fluorescence-guided surgery for pancreatic cancer using panitumumab-IRDye800CW: a phase 1 single-centre, open-label, single-arm, dose-escalation study.

Guolan Lu, Nynke S van den Berg, Brock A Martin, Naoki Nishio, Zachary P Hart, Stan van Keulen, Shayan Fakurnejad, Stefania U Chirita, Roan C Raymundo, Grace Yi and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in The lancet. Gastroenterology & hepatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03384238 (A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Pancreas Cancer During Surgical Procedures), which is not on this map. Cited by 70 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 5% 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.

NCT03384238 phase1 / phase2recruitingnot on this map

A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Pancreas Cancer During Surgical Procedures

TypeinterventionalSponsorGeorge PoultsidesRan2018 to 2027Enrolled27ConditionsPancreatic AdenocarcinomaArmsFluorescence Imaging, Panitumumab, Panitumumab-IRDye800
3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 1 synthesis or guideline pooled it, 95 citations in OpenAlex.

  1. Pooled it
  2. 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
  3. More Than a Glow: How Cyanine Dyes Shape Tracer Pharmacokinetics.Angewandte Chemie (International ed. in English) · 2026
    Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Review
  16. Optical and Optoacoustic Imaging.Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer · 2026
    Review
  17. Article
  18. Article
  19. Article
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Guolan LuDepartment of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford University, CA, USA.
Nynke S van den BergDepartment of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford University, CA, USA.
Brock A MartinDepartment of Pathology, Stanford University School of Medicine, Stanford University, CA, USA.
Naoki NishioDepartment of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford University, CA, USA.
Zachary P HartDepartment of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford University, CA, USA.
Stan van KeulenDepartment of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford University, CA, USA.
Shayan FakurnejadDepartment of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford University, CA, USA.
Stefania U ChiritaDepartment of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford University, CA, USA; Cancer Clinical Trials Office, Stanford University School of Medicine, Stanford University, CA, USA.
Roan C RaymundoDepartment of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford University, CA, USA; Cancer Clinical Trials Office, Stanford University School of Medicine, Stanford University, CA, USA.
Grace YiDepartment of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford University, CA, USA; Cancer Clinical Trials Office, Stanford University School of Medicine, Stanford University, CA, USA.
Quan ZhouDepartment of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford University, CA, USA.
George A FisherDepartment of Medical Oncology, Stanford University School of Medicine, Stanford University, CA, USA.
Eben L RosenthalDepartment of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford University, CA, USA; Stanford Cancer Center, Stanford University School of Medicine, Stanford University, CA, USA.
George A PoultsidesDepartment of Surgery, Stanford University School of Medicine, Stanford University, CA, USA. Electronic address: gpoultsides@stanford.edu.
Stanford University · US

Funding

Stanford Molecular Imaging Scholars (SMIS) ProgramT32CA118681 · NCI · STANFORD UNIVERSITY · PI CRAIG S LEVIN · 2016 to 2026
$4.3M
Prototype optical device for image guided surgery with panitumumab-IRDye800R01CA190306 · NCI · STANFORD UNIVERSITY · PI ROSENTHAL, EBEN L. · 2015 to 2019
$2.6M
NCI NIH HHS R01 CA190306NCI NIH HHS T32 CA118681
6 · The paper itself

Abstract

backgroundComplete surgical resection remains the primary curative option for pancreatic ductal adenocarcinoma, with positive margins in 30-70% of patients. In this study, we aimed to evaluate the use of intraoperative tumour-specific imaging to enhance a surgeon's ability to detect visually occult cancer in real time.

methodsIn this single-centre, open-label, single-arm study, done in the USA, we enrolled patients who had clinically suspicious or biopsy-confirmed pancreatic ductal adenocarcinomas and were scheduled for curative surgery. Eligible patients were 19 years of age or older with a life expectancy of more than 12 weeks and a Karnofsky performance status of at least 70% or an Eastern Cooperative Oncology Group or Zubrod level of one or lower, who were scheduled to undergo curative surgery. Patients were sequentially enrolled into each dosing group and 2-5 days before surgery, patients were intravenously infused with 100 mg of unlabelled panitumumab followed by 25 mg, 50 mg, or 75 mg of the near-infrared fluorescently labelled antibody (panitumumab-IRDye800CW). The primary endpoint was to determine the optimal dose of panitumumab-IRDye800CW in identifying pancreatic ductal adenocarcinomas as measured by tumour-to-background ratio in all patients. The tumour-to-background ratio was defined as the fluorescence signal of the tumour divided by the fluorescence signal of the surrounding healthy tissue. The dose-finding part of this study has been completed. This study is registered with ClinicalTrials.gov, NCT03384238.

findingsBetween April, 2018, and July, 2019, 16 patients were screened for enrolment onto the study. Of the 16 screened patients, two (12%) patients withdrew from the study and three (19%) were not eligible; 11 (69%) patients completed the trial, all of whom were clinically diagnosed with pancreatic ductal adenocarcinoma. The mean tumour-to-background ratio of primary tumours was 3·0 (SD 0·5) in the 25 mg group, 4·0 (SD 0·6) in the 50 mg group, and 3·7 (SD 0·4) in the 75 mg group; the optimal dose was identified as 50 mg. Intraoperatively, near-infrared fluorescence imaging provided enhanced visualisation of the primary tumours, metastatic lymph nodes, and small (<2 mm) peritoneal metastasis. Intravenous administration of panitumumab-IRDye800CW at the doses of 25 mg, 50 mg, and 75 mg did not result in any grade 3 or higher adverse events. There were no serious adverse events attributed to panitumumab-IRDye800CW, although four possibly related adverse events (grade 1 and 2) were reported in four patients.

interpretationTo our knowledge, this study presents the first clinical use of panitumumab-IRDye800CW for detecting pancreatic ductal adenocarcinomas and shows that panitumumab-IRDye800CW is safe and feasible to use during pancreatic cancer surgery. Tumour-specific intraoperative imaging might have added value for treatment of patients with pancreatic ductal adenocarcinomas through improved patient selection and enhanced visualisation of surgical margins, metastatic lymph nodes, and distant metastasis.

fundingNational Institutes of Health and the Netherlands Organization for Scientific Research.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalBenzenesulfonatesCarcinoma, Pancreatic DuctalFemaleHumansIndolesInfusions, IntravenousIntraoperative PeriodLymphatic MetastasisMaleMargins of ExcisionMiddle AgedNeoplasm StagingAntineoplastic Agents, ImmunologicalBenzenesulfonatesIndolesIRDye 800CWPanitumumab

Identifiers

PMID32416764
PMCPMC7367758
OpenAlexW3024949407

What OpenQuestion holds

Textmetadata
LicenceTDM
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.