Actively Recruiting
Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.
Led by John Waters · Updated on 2025-09-24
50
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
Sponsors
J
John Waters
Lead Sponsor
O
On Target Laboratories, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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 Participate
Eligibility Criteria
You may qualify if you...
- Male and Female patients 18 years of age and older
- Primary diagnosis or high suspicion of gastrointestinal, foregut, pancreatic, hepatobiliary, esophageal, or gynecologic malignancies planned for HIPEC/debulking surgery
- Scheduled for surgical tumor resection or diagnostic laparoscopy to assess disease burden
- Willing to stop folate, folic acid, or folate-containing supplements at least 48 hours before CYTALUX administration
- Willing to provide written informed consent or have a legal guardian/representative provide consent
You will not qualify if you...
- Any medical condition that may jeopardize safety as judged by investigators
- History of anaphylactic reactions to indocyanine green or near-infrared imaging products
- History of allergy to any components of CYTALUX (pafolacianine) injection
- Psychological, familial, sociological, or geographical issues that may affect study compliance or follow-up
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clemments University Hospital
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
J
John Waters, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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