Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07039526 | Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer. | PHASE2 | RECRUITING | 50 | — | — | Aug 19, 2025 | Dec 1, 2027 | Sep 24, 2025 | 1 | United States |
Proportion of subjects who have one or more NIR fluorescence positive lesion not detected under normal light and/or palpation will be measured in this outcome.
| Arm | Type | Description |
|---|---|---|
| CYTALUX™ (pafolacianine) injection group | EXPERIMENTAL | Single arm study, every patient receives the study intervention. |
| Name | Type | Description |
|---|---|---|
| CYTALUX™ (pafolacianine) injection preoperatively | DRUG | CYTALUX™ (pafolacianine) injection: folate analog ligand conjugated with an indole cyanine green-like dye as a solution in vials containing 1.6 mL at 2 mg/mL. Each subject will be administered a single intravenous dose of not less than 1 hours before and not more than 24 hours before initiation of intraoperative NIR fluorescent imaging. |
Inclusion Criteria: 1. Male and Female patients 18 years of age and older 2. Have a primary diagnosis, or a high clinical suspicion, of gastrointestinal, fore gut, pancreatic, hepatobiliary, esophageal malignancies and gyn malignancies planned for HIPEC/debulking, warranting surgery. 3. Are schedul...