Evidence map›Paper›PMID 36070540›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006).

Janos L Tanyi, Leslie M Randall, Setsuko K Chambers, Kristina A Butler, Ira S Winer, Carrie L Langstraat, Ernest S Han, Alexander L Vahrmeijer, Hye Sook Chon, Mark A Morgan and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07469202 (Prospective, Multi Center, Open Label Non Inferiority Trial Evaluating the Clinical Adequacy of Intraoperative Tumor Fluorescence With Cytalux™), which is not on this map. Cited by 101 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
101citing papers in PubMed, 2 pooled it
24.6field-weighted citation impact, top 1% 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.

NCT07469202 phase4not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Prospective, Multi Center, Open Label Non Inferiority Trial Evaluating the Clinical Adequacy of Intraoperative Tumor Fluorescence With Cytalux™ (Pafolacianine) Across Two Preoperative Administration Windows in Adults Undergoing Surgery for Suspected Lung Cancer or Confirmed Ovarian Cancer

TypeinterventionalSponsorOn Target Laboratories, LLCRan2026 to 2027Enrolled106ConditionsCancer in the Lung, Ovarian CancerArmsCYTALUX (pafolacianine) injection
3 · Its place in the literature

Who cites it

101 citing papers in PubMed, 2 syntheses or guidelines pooled it, 150 citations in OpenAlex.

  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. Trial
  5. 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
  6. Trial
  7. Article
  8. Imaging the hallmarks of cancer.Nature reviews. Cancer · 2026
    Review
  9. Review
  10. Review
  11. Article
  12. Translation of Intraoperative Molecular Imaging for Clinical Use.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Review
  13. Erasable FAP Targeted Spray-On Probe for Fluorescence-Guided Surgery.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Article

41 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 11 institutions in 2 countries.

Janos L TanyiHospital of the University of Pennsylvania, Abramson Cancer Center, West Pavilion, Philadelphia, PA.ORCID 0000-0002-5657-3698
Leslie M RandallVirginia Commonwealth University Health, Massey Cancer Center, Richmond, VA.ORCID 0000-0003-3790-4858
Setsuko K ChambersUniversity of Arizona Cancer Center, Tucson, AZ.
Kristina A ButlerMayo Clinic Hospital-Phoenix, Phoenix, AZ.
Ira S WinerKarmanos Cancer Institute, Detroit, MI.
Carrie L LangstraatMayo Clinic-Rochester, Rochester, MI.ORCID 0000-0001-9361-8392
Ernest S HanCity of Hope Comprehensive Cancer Center, Duarte, CA.ORCID 0000-0001-6224-8544
Alexander L VahrmeijerLeiden University, Leiden, the Netherlands.
Hye Sook ChonMoffitt Cancer Center, Tampa, FL.
Mark A MorganHospital of the University of Pennsylvania, Abramson Cancer Center, Philadelphia, PA.ORCID 0000-0001-5245-1709
Matthew A PowellWashington University-St Louis, St Louis, MO.ORCID 0000-0002-1968-2772
Jill H TsengUniversity of California-Irvine, Orange, CA.
Alexis S LopezMoffitt Cancer Center, Tampa, FL.
Robert M WenhamMoffitt Cancer Center, Tampa, FL.ORCID 0000-0002-6156-8885
Moffitt Cancer Center · USHospital of the University of Pennsylvania · USCity of Hope · USLeiden University · NLMayo Clinic · USPhoenix (United States) · USThe Barbara Ann Karmanos Cancer Institute · USUniversity of Arizona · USUniversity of California, Irvine · USVirginia Commonwealth University · USWashington University in St. Louis · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI John L. Cleveland · 1998 to 2026
$93.5M
Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI PAUL M STEMMER · 1985 to 2026
$68.4M
NCI NIH HHS P30 CA022453NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

purposeThe adjunctive use of intraoperative molecular imaging (IMI) is gaining acceptance as a potential means to improve outcomes for surgical resection of targetable tumors. This confirmatory study examined the use of pafolacianine for real-time detection of folate receptor-positive ovarian cancer.

methodsThis phase III, open-label, 11-center study included subjects with known or suspected ovarian cancer, scheduled to undergo cytoreductive surgery. The objectives were to confirm safety and efficacy of pafolacianine (0.025 mg/kg IV), given ≥ 1 hour before intraoperative near-infrared imaging to detect macroscopic lesions not detected by palpation and normal white light.

resultsFrom March 2018 through April 2020, 150 patients received a single infusion of pafolacianine (safety analysis set); 109 patients with folate receptor-positive ovarian cancer comprised the full analysis set for efficacy. In 33.0% of patients (95% CI, 24.3 to 42.7;

conclusionThis phase III study of pafolacianine met its primary efficacy end point, identifying additional cancers not otherwise identified or planned for resection. Pafolacianine may offer an important real-time adjunct to current surgical approaches for ovarian cancer.

Indexed as

Folate Receptor 1Ovarian NeoplasmsFemaleFolic AcidHumansMolecular ImagingFolate Receptor 1Folic AcidPafolacianine

Identifiers

PMID36070540
PMCPMC12684809
OpenAlexW4294892020

What OpenQuestion holds

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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.