CYTALUX for Intraoperative Imaging of Patients With Endometrial Cancer

NCT07278986 | Recruiting Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: UPCC 22825
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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

CYTALUX (Pafolacianine) Injection; Planned Diagnostic Laparoscopies; Endometrial Cancer; Near Infrared Fluorescence Imaging

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  The primary efficacy endpoint is the sensitivity of CYTALUX with NIR imaging for detection of malignant lesions. Sensitivity is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be cancer relative to the total number of lesions confirmed to be cancer. Sensitivity = (True Positive)/(True Positive + False Negative)

  2 months after surgery

Secondary Outcomes (1)

• Secondary Endpoints

  2 months after surgery

Study Arms (1)

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

OTHER

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

Drug: CYTALUX™ (pafolacianine); Device: 1788 4K Camera System with Advanced Imaging Modality

Interventions

1788 4K Camera System with Advanced Imaging Modality DEVICE

Combination Product

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

CYTALUX™ (pafolacianine) DRUG

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or positive pregnancy test
• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (2)

Abramson Cancer Center at Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pennsylvania Gynecologic Oncology Department

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Pafolacianine

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Brianna Aguilar

CONTACT

215-615-6770; brianna.aguilar@pennmedicine.upenn.edu

Joseph Agyemang

CONTACT

215-490-4121; joseph.agyemang@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single center, single dose, open-label investigator-initiated pilot study in adult subjects with a primary diagnosis of endometrial cancer who are being evaluated for surgery. Subjects will receive one dose of CYTALUX™ (pafolacianine) injection intravenously prior to the planned diagnostic laparoscopies. This hour-long infusion will be completed from 1 hour to up to 168 hours (7 days) prior to intraoperative near-infrared (NIR) imaging for the planned surgery. All subjects participating in the study are expected to receive CYTALUX™ 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.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: October 18, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)