Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)

NCT07124351 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STUDY00003515
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label study in adults to determine feasibility of using CYTALUX™ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for detecting any type adenocarcinoma (gastric, esophageal and appendiceal).

Conditions

Gastrointestinal Cancer; Gastric Cancer; Esophageal Cancer; Appendiceal Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of CYTALUX™ (pafolacianine) with near-infrared (NIR) fluorescent imaging

  Determine feasibility of using CYTALUX™ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for detecting any type adenocarcinoma (gastric, esophageal and appendiceal) in at least 70% of the patients.

  12 months

Secondary Outcomes (1)

• Number of Lesions

  12 months

Study Arms (1)

CYTALUX™ (pafolacianine)

EXPERIMENTAL

Enrolled subjects will be dosed with 0.025 mg/kg CYTALUX™ (pafolacianine) injection intravenously, with the hour-long infusion completing from 1 hour to up to 24 hours prior to imaging for the planned surgery.

Drug: CYTALUX™ (pafolacianine)

Interventions

CYTALUX™ (pafolacianine) DRUG

All subjects participating in the study are expected to receive CYTALUX™ (pafolacianine) injection and standard care surgery; 1 to 24 hours after CYTALUX™ (pafolacianine) injection infusion is completed, all tumors planned to be removed as part of standard care will undergo assessment with NIR light imaging both intraoperatively and on the back table following surgery.

CYTALUX™ (pafolacianine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age and older of any sex.
• 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).
• Have an indication for surgical intervention for gastroesophageal tumor resection or diagnostic laparoscopy for assessment of peritoneal disease burden.
• Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX.
• Willingness of research participant to give written informed consent.

You may not qualify if:

• 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.
• Known sensitivity to fluorescent light.
• Women of childbearing potential who are pregnant or plan to become pregnant during the study.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• On Target Laboratories, LLC: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Appendiceal Neoplasms

Interventions

Pafolacianine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Cecal Neoplasms; Intestinal Neoplasms; Cecal Diseases; Intestinal Diseases

Study Officials

• Miguel Burch, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Hoang

CONTACT

310-423-1542; amy.hoang@cshs.org

Laura Sarmiento

CONTACT

310-423-4295; laura.sarmiento@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 15, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

US (1)