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RecruitingNCT07124351Updated Sep 15, 2025

Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)

A Phase 4 interventional study of CYTALUX™ (pafolacianine) in Gastrointestinal Cancer, Gastric Cancer and Esophageal Cancer, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Cedars-Sinai Medical Center · Phase 4, Interventional, and Diagnostic

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Gastrointestinal Cancer
  • Gastric Cancer
  • Esophageal Cancer
  • Appendiceal Cancer
03

In context

Gastrointestinal Neoplasms

779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.

This study's planned enrollment of 15 is below the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.

Browse Gastrointestinal Neoplasms studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients 18 years of age and older of any sex.
  2. Have a primary diagnosis, or a high clinical suspicion, of gastroesophageal adenocarcinoma based on CT (computed tomography)/PET (positron emission tomography) or other imaging (Cohort 1) or diagnosis of appendiceal adenocarcinoma with a high clinical suspicion of peritoneal carcinomatosis (Cohort 2).
  3. Have an indication for surgical intervention for gastroesophageal tumor resection or diagnostic laparoscopy for assessment of peritoneal disease burden.
  4. Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of CYTALUX.
  5. Willingness of research participant to give written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject.
  2. History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
  3. History of allergy to any of the components of CYTALUX™ (pafolacianine) injection.
  4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule.
  5. Known sensitivity to fluorescent light.
  6. Women of childbearing potential who are pregnant or plan to become pregnant during the study.
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study 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.

    Drug: CYTALUX™ (pafolacianine)

Interventions

  • DrugCYTALUX™ (pafolacianine)

    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.

06

What researchers measure

Primary outcomes

  1. Feasibility of CYTALUX™ (pafolacianine) with near-infrared (NIR) fluorescent imaging

    Determine feasibility of using CYTALUX™ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for detecting any type adenocarcinoma (gastric, esophageal and appendiceal) in at least 70% of the patients.

    Time frame: 12 months

Secondary outcomes

  1. Number of Lesions

    Number of lesions that are simultaneously fluorescence positive and cancer positive.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07124351
Lead sponsor
Cedars-Sinai Medical Center
Collaborators
On Target Laboratories, LLC
Responsible party
Miguel Burch (Principal Investigator, Cedars-Sinai Medical Center) — Principal investigator
First posted
Aug 15, 2025
Start date
Sep 5, 2025
Primary completion
Aug 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Sep 15, 2025

Study contacts

Amy Hoang
Contact
amy.hoang@cshs.org
310-423-1542
Laura Sarmiento
Contact
laura.sarmiento@cshs.org
310-423-4295
Miguel Burch, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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