CYTALUX for Intraoperative Imaging of Patients With Endometrial Cancer

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 Criteria:

1. Provision of signed and dated informed consent form
2. Adult subjects 18 years of age and older
3. Primary diagnosis of endometrial cancer
4. Scheduled to undergo surgery for endometrial cancer
5. Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
6. Willingness to stop the use of folate or folic acid supplements at least 48 hours prior to infusion of study drug

Exclusion Criteria:

1. Pregnancy or positive pregnancy test
2. Any medical condition that in the opinion of the investigator could potentially jeopardize the safety of the subject
3. History of anaphylactic reactions to products containing indocyanine green
4. History of allergy to any of the components of CYTALUX
5. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule

Conditions5

Locations2 sites

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