NCT07124351 Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
| NCT ID | NCT07124351 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Cedars-Sinai Medical Center |
| Condition | Gastrointestinal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 15 participants in total. It began in 2025-09-05 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Miguel Burch, MD
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT07124351 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07124351 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07124351 currently recruiting?
Yes, NCT07124351 is actively recruiting participants. Contact the research team at amy.hoang@cshs.org for enrollment information.
Where is the NCT07124351 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT07124351 clinical trial?
NCT07124351 is sponsored by Cedars-Sinai Medical Center. The principal investigator is Miguel Burch, MD at Cedars-Sinai Medical Center. The trial plans to enroll 15 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.