Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CYTALUX™ (pafolacianine) injection preoperatively
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...
Top 20 of 36 competitors
CYTALUX preoperatively, also known as CYTALUX™ (pafolacianine) injection preoperatively, is being studied for use in esophageal cancer. It is an investigational small molecule being evaluated in a Phase 2 clinical trial for the intraoperative detection of malignant tissue during surgical resection.
CYTALUX preoperatively is a small molecule that is being investigated for its ability to help surgeons identify malignant tissue during surgery. The specific molecular target is not disclosed in the available information, but the drug is designed to aid in the intraoperative detection of cancer cells.
CYTALUX preoperatively is being developed by Waters Corporation, which is publicly traded under the ticker symbol WAT. The company is conducting a Phase 2 clinical trial to evaluate the drug for the intraoperative detection of malignant tissue in patients undergoing surgical resection for cancer.
CYTALUX preoperatively is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing trial is a single-dose, investigator-initiated pilot study that is currently recruiting participants in the United States.
CYTALUX preoperatively is being evaluated in a Phase 2 clinical trial with the identifier NCT07039526. This trial is a single-dose, investigator-initiated pilot study investigating the drug for intraoperative detection of malignant tissue in subjects undergoing surgical resection for cancer, including esophageal, gastrointestinal, and gynecologic cancers. The trial is recruiting 50 participants in the United States.
Yes, CYTALUX preoperatively is the same as CYTALUX™ (pafolacianine) injection preoperatively. The drug is also known by this alternative name, which includes the brand name CYTALUX and the generic name pafolacianine, and it is administered as an injection before surgery.