Abramson Cancer Center at Penn Medicine
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.
Study participant's medical history (questions about their health) will be reviewed with them before their surgery to ensure they are able to participate in the study. It is important for study participants to tell their doctor if they are taking vitamins that contain Folic Acid (vitamin B9), or Folic Acid (vitamin B9) supplements. They will need to stop taking these vitamins at least 48 hours before their scheduled infusion. Folic acid can reduce the effectiveness of the CYTALUX (pafolacianine). Certain other medications have not been studied together with CYTALUX (pafolacianine), so it is i…
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 investig…
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
Arctuva estimate
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