NCT07124351RecruitingPhase 4
Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 31 Jul 2025
- Start date
- 5 Sept 2025
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07124351
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 15
- From 5 Sept 2025 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Known sensitivity to fluorescent light.
- Women of childbearing potential who are pregnant or plan to become pregnant during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.