Pemefolacianine imaging for lung cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1b study examines the safety of a single IV dose of Pemefolacianine for Injection in patients with locally advanced or metastatic lung cancer undergoing thoracoscopic or open lung resection. The trial also measures the fluorescence signal at different dose levels and timing, though this signal will not guide the surgical decision in this study. Participants are adults with suspected or confirmed lung cancer and are undergoing planned lung surgery. The primary goal is safety; secondary observations focus on how well the agent fluoresces at various doses and times. The research is conducted at the University of Pennsylvania under the lead sponsorship of Sunil Singhal, with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

Exclusion Criteria:

* 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
* Patients with impaired renal function as defined by a creatinine clearance (CrCl) \<60 mL/min at Screening, according to the Cockcroft-Gault formula ((140 - age) × body weight/plasma creatinine × 72 (× 0.85 for female)
* History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities such as Fridericia's corrected QTc interval (QTcF) \> 470 ms
* History of radiation therapy to the chest
* Received a systemic investigational drug of any kind for any indication within 4 weeks or 5 half-lives prior to administration of Pemefolacianine for Injection and/or the patient has received Pemefolacianine for Injection previously
* Total bilirubin level \>1.5 times upper limit of normal at screening
* Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \> 2.5 times the upper limit of normal (ULN) at screening
* The patient is pregnant, breast feeding, or plans to become pregnant within 6 months of the administration of Pemefolacianine for Injection or has a positive serum pregnancy test at Screening or a positive urine pregnancy test on the day of surgery or day of admission for female subjects of childbearing potential

Where it's running

• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.