Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CYTALUX preoperatively · 1 trial · 3 indications
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...
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