Recruiting
Early Phase 1

CYTALUX

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT07278986

Conditions

Endometrial Cancer

Near Infrared Fluorescence Imaging

CYTALUX (Pafolacianine) Injection

Planned Diagnostic Laparoscopies

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CYTALUX™ (pafolacianine)

1788 4K Camera System with Advanced Imaging Modality

Study Details

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.

Conditions

Endometrial Cancer

Near Infrared Fluorescence Imaging

CYTALUX (Pafolacianine) Injection

Planned Diagnostic Laparoscopies

Study ID

NCT07278986

Start date

Oct 18, 2025

Status verified date

Dec, 2025

Completion date

Feb, 2029

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: CYTALUX™ (pafolacianine) injection and standard care laparoscopic evaluation of disease.

single dose, open-label, pilot study of single dose of CYTALUX (pafolacianine) injection

Interventions

CYTALUX™ (pafolacianine)

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.

1788 4K Camera System with Advanced Imaging Modality

Combination Product

Primary outcome measure

  • Primary Endpoint [ Time Frame: 2 months after surgery ]

Central Contacts and Locations

Locations

Abramson Cancer Center at Penn Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Janos L Tanyi, MD, PhD

University of Pennsylvania Gynecologic Oncology Department

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Janos L Tanyi, MD, PhD

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Keywords

  • Endometrial Cancer
  • Near Infrared Fluorescence Imaging
  • Cytalux (pafolacianine) injection
  • surgery
  • surgery planned
  • camera
  • investigational

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2025-12-12.