NCT07278986RecruitingEarly phase 1
CYTALUX for Intraoperative Imaging of Patients With Endometrial Cancer
Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Imaging of Patients With Endometrial Cancer Planned for Surgery
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 1 Dec 2025
- Start date
- 18 Oct 2025
- Primary completion date
- Oct 2027
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Diseases
- Endometrial cancer
- NCT number
- NCT07278986
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 10
- From 18 Oct 2025 to the primary completion date, Oct 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any medical condition that in the opinion of the investigator could potentially jeopardize the safety of the subject
- History of anaphylactic reactions to products containing indocyanine green
- History of allergy to any of the components of CYTALUX
- Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
Other
- Pregnancy or positive pregnancy test
Who the study is looking for
- Provision of signed and dated informed consent form
- Adult subjects 18 years of age and older
- Primary diagnosis of endometrial cancer
- Scheduled to undergo surgery for endometrial cancer
- Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
- Willingness to stop the use of folate or folic acid supplements at least 48 hours prior to infusion of study drug
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Gynecologic Oncology Department Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Abramson Cancer Center at Penn Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.