Recruiting

CYTALUX™

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT07124351

Conditions

Gastrointestinal Cancer

Gastric Cancer

Esophageal Cancer

Appendiceal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CYTALUX™ (pafolacianine)

Study Details

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

Study ID

NCT07124351

Start date

Sep 5, 2025

Status verified date

Sep, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

CYTALUX™ (pafolacianine)

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.

Primary outcome measure

  • Feasibility of CYTALUX™ (pafolacianine) with near-infrared (NIR) fluorescent imaging [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Sep 15, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2025-09-15.