Pemefolacianine for IMI of Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunil Singhal
About this trial
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.
Eligibility criteria
Qualifiers
Male or Female subjects greater than 18 years of age inclusive, at the time of signing the informed consent.
Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
Are scheduled to undergo surgical thoracoscopy or open surgery (thoracotomy) and resection of the lung.
If of childbearing potential, the patient must have a negative serum pregnancy test at screening, on Day 1 prior to Pemefolacianine for Injection administration, as well as using a medically acceptable form of contraception
Disqualifiers
Contraindications for surgery or any medical condition that in the opinion of the investigator could significantly jeopardize the safety of the subject
No planned surgical use of any other fluorescent optical imaging agent, or exposure to another optical imaging agent within 8 weeks prior to surgery (e.g., Cytalux)
History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study, or known shellfish allergies.
Known sensitivity to fluorescent light
Trial design
Treatments tested in this trial
- Pemefolacianine Cohort 1 in Part A
- Pemefolacianin Cohort 2 in Part B
Treatment groups
12 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sunil Singhal
Lead sponsor
Abramson Cancer Center at Penn Medicine
Sponsor institution
Source ClinicalTrials.gov