NCT07278986 CYTALUX for Intraoperative Imaging of Patients With Endometrial Cancer
| NCT ID | NCT07278986 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-10-18 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-10-18 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07278986 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07278986 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07278986 currently recruiting?
Yes, NCT07278986 is actively recruiting participants. Contact the research team at brianna.aguilar@pennmedicine.upenn.edu for enrollment information.
Where is the NCT07278986 trial being conducted?
This trial is being conducted at Philadelphia, United States, Philadelphia, United States.
Who is sponsoring the NCT07278986 clinical trial?
NCT07278986 is sponsored by Abramson Cancer Center at Penn Medicine. The trial plans to enroll 10 participants.
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