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CYTALUX for Intraoperative Imaging of Patients With Endometrial Cancer

NCT07278986 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-12

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

CYTALUX™ (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.

DEVICE

1788 4K Camera System with Advanced Imaging Modality

Combination Product

Sponsors & Collaborators

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-18
Primary Completion
2027-10-31
Completion
2029-02-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07278986 on ClinicalTrials.gov