RecruitingEarly Phase 1NCT07278986

CYTALUX for Intraoperative Imaging of Patients With Endometrial Cancer

Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Imaging of Patients With Endometrial Cancer Planned for Surgery

Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

10 participants

Start Date

Oct 18, 2025

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer Near Infrared Fluorescence Imaging CYTALUX (Pafolacianine) Injection Planned Diagnostic Laparoscopies

Summary

The research study is being done to assess the safety and ability of an investigational drug called CYTALUX (pafolacianine) and a special camera system for the detection of cancer in patients undergoing surgical resection for endometrial cancer.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing CYTALUX (pafolacianine), a fluorescent dye that makes cancer tissue glow under special surgical lights, to help surgeons see and remove endometrial (uterine) cancer more completely during surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with endometrial (uterine) cancer - You are scheduled to have surgery for your endometrial cancer - You are willing to stop taking folic acid or folate supplements for at least 48 hours before the dye is given **You may NOT be eligible if...** - You are pregnant or have a positive pregnancy test - You have had a serious allergic reaction (anaphylaxis) to indocyanine green (a dye used in some imaging tests) - You have a known allergy to any component of CYTALUX - You have a medical condition that in the investigator's opinion makes participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCYTALUX™ (pafolacianine)

CYTALUX™ (pafolacianine) injection and standard care laparoscopic evaluation of disease. Intraoperative imaging with Cytalux will be performed for assessment of disease detection in patients who are being evaluated to undergo surgery for endometrial cancer. Any tissues removed as part of standard of care will undergo assessment with NIR light imaging prior to and after resection. This will be then compared to gold standard histologic confirmation by pathology.

DEVICE1788 4K Camera System with Advanced Imaging Modality

Combination Product

Locations(2)

Abramson Cancer Center at Penn Medicine

Philadelphia, Pennsylvania, United States

University of Pennsylvania Gynecologic Oncology Department

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT07278986

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