CYTALUX Dose Extension Study (NCT07469202) | Clinical Trial Compass
Not Yet RecruitingPhase 4
CYTALUX Dose Extension Study
106 participantsStarted 2026-05-15
Plain-language summary
The goal of this clinical trial is to learn whether giving Cytalux™ (pafolacianine) injection several days before surgery works as well as giving it closer to the time of surgery for helping surgeons see lesions during an operation. This study is being done in adult patients undergoing surgery for malignant or non-malignant lung lesions or for confirmed ovarian cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female patients 18 years of age and older
. Primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging obtained within 4 months of the screening visit, or have a primary diagnosis for ovarian cancer
. Scheduled to undergo surgical thoracoscopy for wedge resection or anatomic lung resection, or ovarian cancer debulking/cytoreduction
. Willingness of research participant or legal guardian/representative to give written informed consent
Exclusion criteria
. History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
. History of allergy to any of the components of Cytalux™ (pafolacianine)
. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
. Known sensitivity to fluorescent light
. Impaired renal function defined as eGFR\< 50 mL/min/1.73m2
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Impaired liver function defined as values \> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>2x ULN for total bilirubin excluding those patients with Gilbert's syndrome
. Pregnant and/or lactating women
. Administration of folate, folic acid, or folate-containing supplements 48 hours before administration of Cytalux™ (pafolacianine)