NCT06511037

PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis

The Impact of Pafolacianine Injection for Intraoperative Imaging on Outcomes of Gastrointestinal Cancer Peritoneal Carcinomatosis - A Pilot Study

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot, single-arm, open label study to evaluate the ability of CYTALUX™ (pafolacianine) to help identify cancerous lesions in subjects with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery.

Conditions

• Gastrointestinal Cancer
• Peritoneal Carcinomatosis

Interventions

Type	Name	Description
DRUG	Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging	Given IV

Timeline

• Start date: 2024-11-13
• Primary completion: 2026-11-30
• Completion: 2027-11-30
• First posted: 2024-07-19
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study