Clinical trial · Interventional
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
NCT07278986CI-TRIAL-00098898CYTALUX ISSrecruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CYTALUX (Pafolacianine) Injection | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Near Infrared Fluorescence Imaging | — | UNRESOLVED | — |
| Planned Diagnostic Laparoscopies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1788 4K Camera System with Advanced Imaging Modality | Device | — | UNRESOLVED |
| CYTALUX™ (pafolacianine) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- CYTALUX™ (pafolacianine) injection and standard care laparoscopic evaluation of disease.
- description
- single dose, open-label, pilot study of single dose of CYTALUX (pafolacianine) injection
- interventionNames
- Drug: CYTALUX™ (pafolacianine)
- Device: 1788 4K Camera System with Advanced Imaging Modality
Primary outcomes (1)
- measure
- Primary Endpoint
- timeFrame
- 2 months after surgery
- description
- 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)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.