CYTALUX for Intraoperative Imaging of Patients With Endometrial Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT07278986
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 1788 4K Camera System with Advanced Imaging Modality — DEVICE
    Combination Product

Study Details

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.

Key Dates

Start date
Oct 18, 2025
Status verified
Dec 2025
Primary completion
Oct 31, 2027
Completion
Feb 28, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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

Primary Outcome Measure

Primary Endpoint [ Time Frame: 2 months after surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center at Penn MedicinePhiladelphiaPennsylvania19104
Brianna Aguilar
[email protected]
215-615-6770
Joseph Agyemang
[email protected]
215-490-4121
Janos L Tanyi, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania Gynecologic Oncology DepartmentPhiladelphiaPennsylvania19104
Brianna Aguilar
[email protected]
215-615-6770
Joseph Agyemang
[email protected]
215-490-4121
Janos L Tanyi, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Abramson Cancer Center at Penn Medicine· Philadelphia, PAUniversity of Pennsylvania Gynecologic Oncology Department· Philadelphia, PA

Related Studies