Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)

Launched by CEDARS-SINAI MEDICAL CENTER · Aug 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help doctors see certain types of gastrointestinal cancers—like stomach, esophagus, and appendix cancers—more clearly during surgery. The study uses a special dye called CYTALUX™ (pafolacianine) that lights up cancer cells under a special camera, helping surgeons find and remove tumors more accurately. This is an early phase study to see if this imaging method is safe and works well in adults who are having surgery for these cancers.

Adults 18 years and older who have been diagnosed with or are strongly suspected to have these cancers, and who are scheduled for surgery, may be eligible. Participants will need to stop taking folate vitamins a couple of days before the study and agree to give written consent. During the surgery, they will receive the CYTALUX™ dye through an injection, and the doctors will use special imaging to look for cancer cells. People with certain allergies, pregnancy, or health concerns that might make the study unsafe won’t be able to join. This study is not yet recruiting participants but aims to improve how doctors detect cancer during operations.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients 18 years of age and older of any sex.
• • 2. Have a primary diagnosis, or a high clinical suspicion, of gastroesophageal adenocarcinoma based on CT (computed tomography)/PET (positron emission tomography) or other imaging (Cohort 1) or diagnosis of appendiceal adenocarcinoma with a high clinical suspicion of peritoneal carcinomatosis (Cohort 2).
• • 3. Have an indication for surgical intervention for gastroesophageal tumor resection or diagnostic laparoscopy for assessment of peritoneal 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 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.
• • 5. Known sensitivity to fluorescent light.
• • 6. Women of childbearing potential who are pregnant or plan to become pregnant during the study.