Evidence map›Paper›PMID 39442905›Full record

Trial reportThe Annals of thoracic surgery2025

Intraoperative Molecular Imaging With Pafolacianine in Resection of Occult Pulmonary Malignancy in the ELUCIDATE Trial.

David Rice, Sunil Singhal, Emma Niemeyer, Inderpal Sarkaria, Linda W Martin, Michael I Ebright, Brian E Louie, Tommy Lee, Jarrod D Predina

Registry-linked trialAbstract readClinical Trial, Phase III
In one paragraph

Trial report in The Annals of thoracic surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04241315 (A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT04241315 phase3completednot on this map

A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

TypeinterventionalSponsorOn Target Laboratories, LLCRan2020 to 2021Enrolled112ConditionsLung Neoplasms, Lung CancerArmsOTL38 for Injection, Near infrared camera imaging system
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Translation of Intraoperative Molecular Imaging for Clinical Use.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Review
  5. Review
  6. 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

9 authors.

David RiceMD Anderson Cancer Center, Houston, Texas.
Sunil SinghalCenter for Precision Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania; Division of Thoracic Surgery, Department of Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Emma NiemeyerCenter for Precision Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania; Division of Thoracic Surgery, Department of Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Inderpal SarkariaUniversity of Texas Southwestern Medical Center, Dallas, Texas.
Linda W MartinSection of Thoracic Surgery, Department of Surgery, University of Virginia School of Medicine, Charlottesville, Virginia.
Michael I EbrightColumbia University Irving Medical Center, New York, New York.
Brian E LouieSwedish Cancer Institute and Medical Center, Seattle, Washington.
Tommy LeeOn Target Laboratories, Inc, West Lafayette, Indiana.
Jarrod D PredinaCenter for Precision Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania; Division of Thoracic Surgery, Department of Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: jarrod.predina@pennmedicine.upenn.edu.

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI Christine O'Connell · 1998 to 2026
$93.5M
Shared Resource - Core A: Administrative CoreP01CA254859 · NCI · UNIVERSITY OF PENNSYLVANIA · PI Sunil Singhal · 2022 to 2026
$10.0M
NCI NIH HHS P01 CA254859NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

backgroundClinical studies have demonstrated that intraoperative molecular imaging (IMI) with pafolacianine identifies occult pulmonary lesions that are not identified by preoperative computed tomography or by intraoperative inspection techniques in ∼20% of patients. This study describes occult lesion clinical data and evaluates characteristics so that surgeons can better incorporate this emerging technology into clinical decision making.

methodsParticipants (n = 100) enrolled in a phase 3 trial of IMI with pafolacianine during pulmonary resection (Enabling Lung Cancer Identification Using Folate Receptor Targeting [ELUCIDATE]; NCT04241315) were identified. Participants underwent preoperative computed tomography with 1.25-mm slices. Patient and lesion characteristics were analyzed. Positive predictive value and false positive rates were tabulated for IMI fluorescent lesions, with predictors of malignant vs benign occult lesions described.

resultsIMI identified 29 occult lesions in 23 (23%) participants. Seventeen of 29 (58%) lesions were identified within the same lobe as known lesions; 12 of 29 (42%) were identified in a different lobe from the suspicious nodule known by preoperative assessment. Twenty-three of 29 (79%) of occult lesions found by IMI were resected with an additional wedge resection. Ten of 29 (34%) lesions identified by IMI were malignant. There was no additional morbidity in participants with lesions resected. With pafolacianine, 7 participants had a synchronous primary stage I lung cancer identified, and 1 participant had additional metastases identified.

conclusionsIMI with pafolacianine identifies occult malignant lesions during pulmonary resection despite thorough preoperative imaging and intraoperative assessment by experienced surgeons.

Indexed as

Lung NeoplasmsMolecular ImagingPneumonectomyAgedFemaleHumansMaleMiddle AgedTomography, X-Ray Computed

Identifiers

PMID39442905
PMCPMC12424048

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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.