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RECRUITING Early Phase 1

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

NCT06511037 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

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

Study Locations (1)

California

  • Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2024-11-13
Est. Completion 2027-11-30
Phase Early Phase 1

Sponsor

University of California, Irvine

353 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06511037

The ClinicalTrials.gov registry entry for NCT06511037 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 353 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Gastrointestinal Cancer appearing as the primary indexed condition, and to 1 intervention — of which Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06511037 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06511037 about?

NCT06511037 is a clinical study titled "PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis". 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.

What is the current status of trial NCT06511037?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2024-11-13. Estimated completion is 2027-11-30.

What conditions does trial NCT06511037 study?

This clinical trial studies the following conditions: Gastrointestinal Cancer, Peritoneal Carcinomatosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06511037?

The interventions under investigation include: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06511037?

This trial is sponsored by University of California, Irvine, which has 353 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06511037 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial