Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT07124351
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CYTALUX™ (pafolacianine) — DRUG
    All subjects participating in the study are expected to receive CYTALUX™ (pafolacianine) injection and standard care surgery; 1 to 24 hours after CYTALUX™ (pafolacianine) injection infusion is completed, all tumors planned to be removed as part of standard care will undergo assessment with NIR light imaging both intraoperatively and on the back table following surgery.

Study Details

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).

Key Dates

Start date
Sep 5, 2025
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: CYTALUX™ (pafolacianine)
    Enrolled subjects will be dosed with 0.025 mg/kg CYTALUX™ (pafolacianine) injection intravenously, with the hour-long infusion completing from 1 hour to up to 24 hours prior to imaging for the planned surgery.

Primary Outcome Measure

Feasibility of CYTALUX™ (pafolacianine) with near-infrared (NIR) fluorescent imaging [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Amy Hoang
[email protected]
310-423-1542

Find similar trials in Los Angeles, CA

By condition
Esophageal cancerGastric cancer
By specialty
OncologyGI oncology
By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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