CYTALUX-guided near-infrared imaging during surgery for endometrial cancer
Official title: Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Imaging of Patients With Endometrial Cancer Planned for Surgery
Run by Abramson Cancer Center at Penn Medicine · NCT07278986 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 10 (estimated) |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Status | Recruiting |
| Started | October 18, 2025 |
| Main results expected | October 2027 |
| Study ends | February 2029 |
| Registry record updated | December 12, 2025 |
| Trial ID | NCT07278986 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Personalized navigation to support rural and Black women with endometrial cancer
This pilot tests a tailored patient-navigation program to help rural and Black patients with endometrial cancer access care and services.
-
CR-002 study in adults with advanced solid tumors
This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors
-
Methylation markers in self-samples to help detect gynecological cancers
This study tests whether self-collected urine and vaginal samples can reveal DNA methylation or other genetic markers that indicate endometrial, ovarian, vulvar, or vaginal cancers in women who are at risk or have postmenopausal bleeding.
-
One-Finger Technique to identify the left upper ureter during para-aortic lymphadenectomy
This study tests a new surgical method to help surgeons find the left upper ureter during open para-aortic lymphadenectomy in women with gynecologic cancers.
-
Liquid biopsy screening for early endometrial cancer in regional China
A non-invasive blood test using cell-free DNA is being tested to see if it can detect early endometrial cancer and tell apart benign from malignant uterine lesions.
-
Radiotherapy for gynecologic cancer with up to 10 metastatic sites
This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.