PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis
NCT06511037 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-02-27
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
- DRUG
-
Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging
Given IV
Sponsors & Collaborators
-
On Target Laboratories
collaborator UNKNOWN -
University of California, Irvine
lead OTHER
Principal Investigators
-
Maheswari Senthil, MD · Chao Family Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-13
- Primary Completion
- 2026-11-30
- Completion
- 2027-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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