Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| On Target Laboratories, LLC | INDUSTRY |
Not provided
Not provided
Not provided
This is an open-label study in adults to determine feasibility of using CYTALUXâ„¢ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for detecting any type adenocarcinoma (gastric, esophageal and appendiceal).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CYTALUXâ„¢ (pafolacianine) | Experimental | Enrolled subjects will be dosed with 0.025 mg/kg CYTALUXâ„¢ (pafolacianine) injection intravenously, with the hour-long infusion completing from 1 hour to up to 24 hours prior to imaging for the planned surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYTALUXâ„¢ (pafolacianine) | Drug | All subjects participating in the study are expected to receive CYTALUXâ„¢ (pafolacianine) injection and standard care surgery; 1 to 24 hours after CYTALUXâ„¢ (pafolacianine) injection infusion is completed, all tumors planned to be removed as part of standard care will undergo assessment with NIR light imaging both intraoperatively and on the back table following surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of CYTALUXâ„¢ (pafolacianine) with near-infrared (NIR) fluorescent imaging | Determine feasibility of using CYTALUXâ„¢ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for detecting any type adenocarcinoma (gastric, esophageal and appendiceal) in at least 70% of the patients. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lesions | Number of lesions that are simultaneously fluorescence positive and cancer positive. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Hoang | Contact | 310-423-1542 | amy.hoang@cshs.org | |
| Laura Sarmiento | Contact | 310-423-4295 | laura.sarmiento@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Miguel Burch, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
Not provided
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D001063 | Appendiceal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000720187 | Pafolacianine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D005767 |
| Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D002430 | Cecal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |