Pemefolacianine for IMI of Lung Cancer
A Phase IB, Single Dose, Open-Label, Dose-escalation Study to Investigate the Safety and Imaging Characteristics of Pemefolacianine for Intraoperative Molecular Imaging of Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of one dose of pemefolacianine, a dye given slowly into a vein, in adults having surgery for known or suspected lung cancer. It also checks how brightly the dye glows at different doses and times. The glow will not guide what tissue is removed during surgery.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older when you sign the consent form.
- Have lung cancer, or have tests that strongly suggest lung cancer.
- Be scheduled for surgery through small cuts or an open chest cut to remove part of the lung.
- If you can become pregnant, have negative blood pregnancy tests at screening and before the study dose, and use an accepted form of birth control.
- Understand the study, give written consent, allow use and sharing of your health information, and agree to follow study rules and return for checks.
Who can't join
- Have a health problem that makes surgery unsafe or could put you at serious risk in the study.
- Plan to use another glowing imaging dye during surgery, or have received another imaging dye within 8 weeks before surgery.
- Have a history of allergic reactions to medicines, including ICG or other study agents; have a shellfish allergy; or be sensitive to fluorescent light.
- Have reduced kidney function, with a creatinine clearance below 60 mL/min, or high liver blood tests: bilirubin above 1.5 times normal or AST or ALT above 2.5 times normal.
- Have a history of serious heart electrical problems or show them on a screening ECG, a test of the heart’s electrical activity. This includes a QTcF above 470 milliseconds.
- Have had radiation treatment to the chest.
- Have recently received an experimental drug that acts throughout the body—within 4 weeks or 5 drug half-lives, the time it takes the body to clear half a dose—or have received pemefolacianine before.
- Be pregnant, be breastfeeding, plan to become pregnant within 6 months after the study dose, or have a positive pregnancy test at screening, admission, or surgery.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
PA
- University of Pennsylvania · Philadelphia, PA 19104Azra Din, MPH · Study contact · 215-615-7980 · azra.din@pennmedicine.upenn.eduMore trials in Philadelphia