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 Cytaluxâ„¢ (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 range18 Years
SexALL
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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
✕. 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