Using CYTALUX (pafolacianine) with a near-infrared camera to help find cancer during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 pilot gives adult surgical patients a single preoperative IV dose of CYTALUX (pafolacianine), a folate-receptor–targeted near-infrared fluorescent agent, and then uses an intraoperative NIR camera to visualize tumor tissue in real time. Participants are adults with a known or high clinical suspicion of GI, foregut, pancreatic, hepatobiliary, esophageal, or gynecologic malignancy who are scheduled for resection, debulking/HIPEC, or diagnostic laparoscopy. The surgical team records whether fluorescence improves detection of malignant tissue, including occult lesions and margin delineation, and participants are followed through the perioperative period for safety and imaging outcomes. The trial is single-dose and brief, with follow-up visits to document any adverse events and correlation of imaging with histopathology.

Why it matters

Who can join: the full rules

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

Where it's running

• Clemments University Hospital
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: John Waters, M.D. — University of Texas Southwestern Medical Center
• Study coordinator: John Waters, M.D.
• Email: john.waters@utsouthwestern.edu
• Phone: 214-645-7700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.