Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.

Launched by JOHN WATERS · Jun 17, 2025

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ClinConnect Summary

This clinical trial is studying a special drug called CYTALUX™ (pafolacianine) that helps surgeons see cancer during an operation. The drug attaches to cancer cells and makes them light up when viewed through a special camera using near-infrared light. This can help doctors find and remove cancer more accurately in people with certain types of cancers, including esophageal, gastrointestinal, pancreatic, liver-related, and gynecologic cancers. The main goal is to see if using this glowing drug during surgery can better detect cancerous tissue compared to the usual methods.

Adults 18 years and older who have or are strongly suspected of having these types of cancers and are scheduled for surgery to remove tumors may be eligible. Participants will receive the drug before surgery, and during the operation, the surgical team will use the special camera to look for glowing cancer cells. The entire process, including follow-up, will take about two months. People taking part will need to avoid folate vitamins for two days before the drug is given and must be willing to sign a consent form. Those with certain allergies or health issues that might make the drug unsafe won’t be able to join. This study is not yet recruiting but aims to improve how cancer is detected during surgery, which could help surgeons remove cancer more completely.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male and Female patients 18 years of age and older
• • 2. Have a primary diagnosis, or a high clinical suspicion, of gastrointestinal, fore gut, pancreatic, hepatobiliary, esophageal malignancies and gyn malignancies planned for HIPEC/debulking, warranting surgery.
• • 3. Are scheduled to undergo surgical intervention for tumor resection or diagnostic laparoscopy for assessment of disease burden.
• • 4. Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of Cytalux
• • 5. Willingness of research participant or legal guardian/representative to give written informed consent.
• Exclusion Criteria:
• • 1. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
• • 2. History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
• • 3. History of allergy to any of the components of CYTALUX™ (pafolacianine) injection
• • 4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule