CYTALUX for Imaging Endometrial Cancer During Surgery
This study is testing a special drug called CYTALUX (pafolacianine) and a camera system to help doctors find endometrial cancer (cancer of the uterus lining) during surgery. The goal is to see how safe and effective CYTALUX is at highlighting cancer cells. You might be able to join if you are an adult woman with endometrial cancer who is scheduled for surgery. The study aims to enroll 10 participants. Success will be measured by how well CYTALUX helps detect cancer during surgery, with results checked about two months after your operation. The current status of this study is unclear.
- Study design
- This is an interventional study involving 10 participants. It tests CYTALUX (pafolacianine) injection alongside standard laparoscopic evaluation.
- What's involved
- You will have a screening visit up to 30 days before surgery, which includes a health review and medication check. You will need to stop taking folic acid supplements at least 48 hours before your CYTALUX infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 2 months after surgery, indicating follow-up for at least that duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CYTALUX for Intraoperative Imaging of Patients With Endometrial Cancer
At a glance
Conditions
Where it's being run
2 sites across 1 statesWho to contact
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What this trial measures
- Primary Endpoint2 months after surgery
The primary efficacy endpoint is the sensitivity of CYTALUX with NIR imaging for detection of malignant lesions. Sensitivity is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be cancer relative to the total number of lesions confirmed to be cancer. Sensitivity = (True Positive)/(True Positive + False Negative)