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Study identifier: NCT07039526 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Esophageal Cancer · Gastrointestinal Cancers · Gynecologic Cancers  ·  Sponsor: John Waters

PhasePhase 2
Planned participants50
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this 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.

This description comes directly from the study's public registry record.

Talk to the study team

John Waters, M.D.  ·  214-645-7700  ·  john.waters@utsouthwestern.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Clemments University HospitalDallas, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07039526