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
Abramson Cancer Center at Penn Medicine
10 participants
Oct 18, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- Provision of signed and dated informed consent form
- Adult subjects 18 years of age and older
- Primary diagnosis of endometrial cancer
- Scheduled to undergo surgery for endometrial cancer
- Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
- Willingness to stop the use of folate or folic acid supplements at least 48 hours prior to infusion of study drug
Exclusion Criteria5
- Pregnancy or positive pregnancy test
- Any medical condition that in the opinion of the investigator could potentially jeopardize the safety of the subject
- History of anaphylactic reactions to products containing indocyanine green
- History of allergy to any of the components of CYTALUX
- Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
Interventions
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.
Combination Product
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07278986