Glow-in-the-dark dye could light up lung tumors during surgery
NCT ID NCT07772895
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental imaging agent called pemefolacianine in people with lung cancer who are scheduled for surgery. The agent is given as an injection before the operation, and researchers will check whether it safely makes cancer tissue glow under special light, potentially helping surgeons see and remove tumors more precisely. The study focuses on safety first, then on how well the fluorescence works at different doses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pemefolacianine, an experimental fluorescence imaging agent given by intravenous injection before surgery
- What this could lead to
- If successful, this could help surgeons see lung cancer more clearly during operations, potentially leading to more complete tumor removal.
- What could go wrong
- This is an early-phase trial with only 12 participants, so results may not apply broadly. The imaging agent may not produce a clear signal or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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