Evidence map›Paper›PMID 33221195›Full record

Trial reportThe Annals of thoracic surgery2021

Multiinstitutional Phase 2 Clinical Trial of Intraoperative Molecular Imaging of Lung Cancer.

Sidhu Gangadharan, Inderpal N Sarkaria, David Rice, Sudish Murthy, Jerry Braun, John Kucharczuk, Jarrod Predina, Sunil Singhal

3 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The Annals of thoracic surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
3.3field-weighted citation impact, top 6% 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.

NCT07385430 phase1recruitingnot on this mapstarted 2026, after this paper: background citation

Phase 1 Study of LGW16-03 To Identify Nerves

TypeinterventionalSponsorEric R. HendersonRan2026 to 2027Enrolled38ConditionsAdults, Open-field Surgery, Major NerveArmsLGW16-03
NCT07487883 recruitingnot on this mapstarted 2026, after this paper: background citation

A Single-arm, Open-label, Single-center Clinical Study to Evaluate CDH3-targeted Positron Emission Tomography (PET) for Lung Malignant Tumors

TypeobservationalSponsorPeking University People's HospitalRan2026 to 2027Enrolled80ConditionsNon-Small Cell Lung Cancer, Malignant Neoplasm, Pulmonary Nodules, PET/CTArmsPET/CT scans
NCT07498933 recruitingnot on this mapstarted 2025, after this paper: background citation

Visualization Study on Tumor Progression Mechanisms and Key Molecular Functions in Neoadjuvant Immunotherapy for Lung Cancer: Preoperative Efficacy Prediction and Intraoperative Fluorescence Navigation

TypeobservationalSponsorPeking University People's HospitalRan2025 to 2027Enrolled200ConditionsNon-Small Cell Lung Cancer, PET/CT, Neoadjuvant TherapyArmsPET/CT scans
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 49 citations in OpenAlex.

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  7. Evaluation of Pafolacianine (CytaluxMolecular imaging and biology · 2026
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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

8 authors at 6 institutions in 2 countries.

Sidhu GangadharanDivision of Thoracic Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Inderpal N SarkariaDivision of Thoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.
David RiceDivision of Thoracic Surgery, MD Anderson Cancer Center, Houston, Texas.
Sudish MurthyDivision of Thoracic Surgery, Cleveland Clinic, Cleveland, Ohio.
Jerry BraunDivision of Thoracic Surgery, University of Leiden, Leiden, the Netherlands.
John KucharczukDepartment of Surgery, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
Jarrod PredinaDepartment of Surgery, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.
Sunil SinghalDepartment of Surgery, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania. Electronic address: sunil.singhal@uphs.upenn.edu.
University of Pennsylvania · USBeth Israel Deaconess Medical Center · USCleveland Clinic · USLeiden University · NLThe University of Texas MD Anderson Cancer Center · USUniversity of Pittsburgh · US

Funding

Near infrared intraoperative molecular imaging of lung adenocarcinomaR01CA193556 · NCI · UNIVERSITY OF PENNSYLVANIA · PI LOW, PHILIP STEWART, SINGHAL, SUNIL · 2016 to 2020
$3.3M
NCI NIH HHS R01 CA193556
6 · The paper itself

Abstract

backgroundIntraoperative molecular imaging (IMI) may improve surgical outcomes during pulmonary resection for lung cancer. A multiinstitutional phase 2 IMI clinical trial was conducted using a near-infrared, folate receptor-targeted contrast agent for lung adenocarcinomas, OTL38. The primary goal was to determine whether OTL38 improved surgeons' ability to identify difficult to find nodules, occult cancers, and positive margins.

methodsPatients with lung nodules received OTL38 (0.025 mg/kg) preoperatively. Patients had IMI sequentially during lung inspection, tumor resection, and margin check. Efficacy was evaluated by occurrence of clinically significant events, occurrences that caused the surgeon to modify the operation or upstage the patient's cancer. Safety was assessed for a single intravenous dose of OTL38.

resultsOf 110 patients recruited, 92 were eligible for analysis. During lung inspection, IMI found 24 additional nodules, 9 (10%) of which were cancers that had not been known preoperatively. During tumor resection, IMI located 11 (12%) lesions that the surgeon could not find. During the margin check, IMI revealed 8 positive margins (9%) that the surgeon thought were negative. Benefits of IMI were pronounced in patients undergoing sublobar pulmonary resections and in patients with ground-glass opacities. There were no serious adverse events. All surgeons felt comfortable with the procedures by 10 cases.

conclusionsIn this phase 2 clinical trial, IMI improved outcomes for 26% of patients. A randomized, multiinstitutional phase 3 clinical trial is underway.

Indexed as

Adenocarcinoma of LungAdultAgedAged, 80 and overFemaleHumansIntraoperative CareLungLung NeoplasmsMaleMiddle AgedMolecular ImagingTomography, X-Ray Computed

Identifiers

PMID33221195
PMCPMC10985531
OpenAlexW3102895998

What OpenQuestion holds

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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.