Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)

Not Applicable

Not yet recruiting

• Conditions: Gastrointestinal Cancer; Gastric Cancer; Esophageal Cancer; Appendiceal Cancer
• Interventions: Drug: CYTALUX™ (pafolacianine)

• Registration Number: NCT07124351
• Lead Sponsor: Cedars-Sinai Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-31
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Primary Completion: 2026-08
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CYTALUX™ (pafolacianine)	CYTALUX™ (pafolacianine)	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of CYTALUX™ (pafolacianine) with near-infrared (NIR) fluorescent imaging	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Lesions	12 months	Number of lesions that are simultaneously fluorescence positive and cancer positive.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States