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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT06511037
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Gastrointestinal Cancer
  • Peritoneal Carcinomatosis

Eligibility Criteria

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

Interventions

  • Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Nov 13, 2024
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pafolacianine (CYTALUX)
    All subjects will receive one single intravenous infusion of 0.025 mg/kg of pafolacianine (CYTALUX) injection prior to anticipated intraoperative imaging planned for cytoreductive surgery.

Primary Outcome Measure

Cytoreduction (CC) Score [ Time Frame: 1 year ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-8839
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868
Maheswari Senthil, MD
[email protected]
877-827-8839

Find similar trials in Orange, CA

By research site
Chao Family Comprehensive Cancer Center, University of California, Irvine· Orange, CA

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