RecruitingPhase 2NCT07039526

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

Sponsor

John Waters

Enrollment

50 participants

Start Date

Aug 19, 2025

Study Type

INTERVENTIONAL

Conditions

Gynecologic Cancers Esophageal Cancer Gastrointestinal Cancers

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a glowing dye called pafolacianine (CYTALUX) — which lights up cancer tissue during surgery when viewed with a special camera — can help surgeons better identify and remove cancer during complex abdominal and gynecological operations. **You may be eligible if...** - You are 18 years old or older - You have a confirmed or strongly suspected cancer of the digestive tract, pancreas, liver, bile ducts, esophagus, or gynecological organs - You are scheduled for surgery including tumor removal or a heated chemotherapy procedure (HIPEC) - You can provide informed consent **You may NOT be eligible if...** - You have a known allergy to the dye or its components - You are pregnant or breastfeeding - Your kidney function is too poor to clear the dye safely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCYTALUX™ (pafolacianine) injection preoperatively

CYTALUX™ (pafolacianine) injection: folate analog ligand conjugated with an indole cyanine green-like dye as a solution in vials containing 1.6 mL at 2 mg/mL. Each subject will be administered a single intravenous dose of not less than 1 hours before and not more than 24 hours before initiation of intraoperative NIR fluorescent imaging.