CYTALUX-guided near-infrared imaging during surgery for endometrial cancer
Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Imaging of Patients With Endometrial Cancer Planned for Surgery
This will test whether giving CYTALUX dye before planned laparoscopic surgery and using a special near-infrared camera helps surgeons find endometrial cancer lesions.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT07278986 on ClinicalTrials.gov |
What this trial studies
Participants will have a medical history review and screening up to 30 days before their scheduled surgery and will stop folic acid supplements at least 48 hours prior to infusion. CYTALUX (pafolacianine) is given by infusion any time from 7 days before surgery up to the day of surgery, followed by intraoperative imaging with a 1788 4K near-infrared camera system. The imaging is used during planned diagnostic laparoscopy to look for fluorescent signals that may identify cancerous tissue not seen with standard white-light surgery. As an early Phase 1 interventional protocol, the primary focus is on safety and the ability of the drug-plus-camera combination to detect disease.
Who should consider this trial
Good fit: Adults aged 18 or older with a primary diagnosis of endometrial cancer who are scheduled for surgical resection and can stop folate/folic acid supplements as required are appropriate candidates.
Not a fit: People who are pregnant, allergic to components of CYTALUX, have had anaphylaxis to indocyanine green, or who will not undergo the planned surgery are unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, surgeons may be better able to identify and remove cancerous tissue during the initial operation, which could reduce missed lesions and need for repeat procedures.
How similar studies have performed: Pafolacianine (CYTALUX) and similar fluorescence-guided imaging approaches have shown promise in prior gynecologic cancer studies, such as ovarian cancer trials, with improved lesion detection compared with white-light inspection.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- Abramson Cancer Center at Penn Medicine — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pennsylvania Gynecologic Oncology Department — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Brianna Aguilar
- Email: brianna.aguilar@pennmedicine.upenn.edu
- Phone: 215-615-6770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.