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.
Male and Female patients 18 years of age and older
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.
Are scheduled to undergo surgical intervention for tumor resection or diagnostic laparoscopy for assessment of disease burden.
Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of Cytalux
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
History of allergy to any of the components of CYTALUX™ (pafolacianine) injection
Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
Single group
CYTALUX™ (pafolacianine) injection preoperatively
DrugCYTALUX™ (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.
Proportion of subjects with one or more NIR fluorescence positive lesion not detected under normal light and/or palpation
Proportion of subjects who have one or more NIR fluorescence positive lesion not detected under normal light and/or palpation will be measured in this outcome.
Number of lesions that are simultaneously fluorescence positive and cancer positive
NIR Imaging will take place at least 1 hour but no more than 24 hours after the end of the administration
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John Waters
Lead sponsor
University of Texas Southwestern Medical Center
Sponsor institution
On Target Laboratories, LLC
Collaborator
