Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
Recruiting
Phase 4
Interventional Study
Gastrointestinal Cancer
Gastric Cancer
Esophageal Cancer
Appendiceal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 15 (estimated)
- Sponsor
- Cedars-Sinai Medical Center · Other
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About This Trial
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).
Trial Locations
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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 adenocarci…
Contacts