Intraoperative imaging of gastrointestinal cancers using pafolacianine (CYTALUX™)

Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)

This trial will test whether an injection of CYTALUX™ (pafolacianine) with near-infrared imaging helps surgeons find gastric, esophageal, or appendiceal adenocarcinomas during surgery in adults.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cedars-Sinai Medical Center (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT07124351 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18 or older with a primary or high clinical suspicion of gastroesophageal adenocarcinoma scheduled for resection (cohort 1) or appendiceal adenocarcinoma with suspected peritoneal carcinomatosis scheduled for diagnostic laparoscopy (cohort 2), who can stop folate supplements and provide informed consent, are ideal candidates.

Not a fit: Patients with non-adenocarcinoma tumors, those not undergoing operative intervention, individuals allergic to indocyanine green–type agents, or tumors that do not take up the dye/express its target are unlikely to benefit.

Why it matters

Potential benefit: If successful, the technique could help surgeons detect more tumor deposits during surgery, enabling more complete resection and more accurate staging.

How similar studies have performed: Pafolacianine-guided near-infrared imaging has demonstrated success in ovarian cancer and early reports in other tumors, but its application to gastroesophageal and appendiceal adenocarcinomas is less established and relatively novel.

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.

Where this trial is running

Los Angeles, California

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

Study contacts

• Principal investigator: Miguel Burch, MD — Cedars-Sinai Medical Center
• Study coordinator: Amy Hoang

Conditions Gastrointestinal Cancer; Gastric Cancer; Esophageal Cancer; Appendiceal Cancer