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

Who can join

Ages 18 and older · All sexes

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

About the study

The goal of clinical trial is to test an FDA approved drug called Pafolacianine that attaches to cancer cells and lights up when seen through a special camera system in adults with a suspected primary diagnosis, or a high clinical suspicion of gastrointestinal, fore gut, pancreatic, hepatobiliary, esophageal malignancies and gyn malignancies planned for HIPEC/debulking, warranting surgery. The main question it aims to answer is:

• Can CYTALUX™ (pafolacianine) injection used with near-infrared (NIR) fluorescent imaging improve the detection of malignant tissue in subjects undergoing surgical resection for cancer? Participants taking part in this study will receive the study medication. Then, during the surgery the investigator team will turn on the camera to evaluate if the tumor is visible with the help of the study medication. Taking part in this study will last about 2 months.

What is being tested

• CYTALUX™ (pafolacianine) injection preoperatively (drug)

Sponsor: John Waters · Participants: 50 · Started: Aug 19, 2025

Contact the study team

• John Waters, M.D. · Phone: 214-645-7700

Official record on ClinicalTrials.gov — NCT07039526

Locations in the U.S.

Conditions

• Esophageal Cancer
• Gastrointestinal Cancers

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.