Sponsor study identifier
interventional
12
1 country
1
Study Start
March 11, 2026
Actual (reported)Primary Completion
March 11, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 11, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of Pemefolacianine for Injection, a novel fluorescence imaging agent developed by Nanjing Nuoyuan Medical Devices Co., Ltd (Nuoyuan Medical), administered by slow intravenous (IV) in patients undergoing surgical thoracoscopy and/or RATS (Robot-Assisted Thoracoscopic Surgery) resection of lung cancer. Safety is the primary objective of this study, followed by evaluation of the fluorescence signal as it relates to dose level and dosing time interval which will not be used for decision-making in the surgical resection in this study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 11, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 11, 2026
Actual (reported)May 21, 2026
Actual (reported)August 19, 2026
Actual (reported)March 11, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 11, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety of Pemefolacianine for Injection, as assessed by the incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant changes in laboratory values, vital signs, physical examinations, and electrocardiograms (ECGs) from baseline through the end of the study.
Day 1 through Day 30
Signal-to-Background Ratio in Intraoperative Tissue Images
Day 2 surgery
The dose of Pemefolacianine for Injection planned to be administered to the first cohort of patients is 0.02 mg/kg.
The patients in second cohort were planned to receive dose Pemefolacianine for Injection at 0.04 mg/kg.
Enrolled subjects arrive at the infusion center for their infusions up to 8-36hours before the scheduled surgery to receive their injection of Pemefolacianine for Injection. cohorts 1 patients will receive dose of 0.02 mg/kg
Enrolled subjects arrive at the infusion center for their infusions up to 8-36hours before the scheduled surgery to receive their injection of Pemefolacianine for Injection. cohorts 2 patients will receive dose of 0.04 mg/kg
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
First Submitted
May 21, 2026
First Posted
August 19, 2026
Study Start
March 11, 2026
Actual (reported)Primary Completion
March 11, 2027
EstimatedRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 11, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 19, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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