Intraoperative imaging of gastrointestinal cancers using pafolacianine (CYTALUX™)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, adult study gives an intravenous dose of pafolacianine prior to surgery and uses near-infrared fluorescent imaging in the operating room to look for adenocarcinoma lesions. Participants are enrolled in two cohorts: patients with a primary or suspected gastroesophageal adenocarcinoma scheduled for tumor resection, and patients with appendiceal adenocarcinoma with suspected peritoneal carcinomatosis undergoing diagnostic laparoscopy. The primary purpose is to determine the feasibility of intraoperative lesion detection and mapping with CYTALUX™. Participants must stop folate-containing supplements shortly before dosing and are excluded if they have a history of severe allergic reactions to indocyanine green–type imaging agents.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Miguel Burch, MD — Cedars-Sinai Medical Center
• Study coordinator: Laura Sarmiento
• Email: Laura.sarmiento@cshs.org
• Phone: 310-423-4295

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.