NCT02784028

Study in Patients With Peritoneal Carcinomatosis From CEA Overexpressing Digestive Cancer

Phase I Study Assessing Safety of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Detection of Neoplastic Lesions in Patients With Peritoneal Carcinomatosis From CEA Overexpressing Digestive Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The digestive cancer is the second cause of death worldwide. The presence of peritoneal carcinomatosis is common in the evolution of this type of cancer, as well as increased levels of ACE. This peritoneal carcinomatosis is often underestimated, this being due to low sensitivity detection means. In recent years, it has been shown that peritoneal carcinomatosis surgery as complete as possible associated with an intraperitoneal chemotherapy gave better results but still failures associated with the presence of microscopic residual tumors. The use of SGM -101 (developped by SURGIMAB SAS) allows surgeons to detect tumor nodules of small size very easily, in real-time, during surgery (shown in animals).

Detailed description

The digestive cancer is the second cause of death worldwide. The presence of peritoneal carcinomatosis is common in the evolution of this type of cancer, as well as increased levels of ACE. This peritoneal carcinomatosis is often underestimated, this being due to low sensitivity detection means. In recent years, it has been shown that peritoneal carcinomatosis surgery as complete as possible associated with an intraperitoneal chemotherapy gave better results but still failures associated with the presence of microscopic residual tumors. SGM -101 (developped by SURGIMAB SAS) is a fluorescent antibody that binds to ACE which is overespressed at the surface of tumor cells. The use of this fluorescent molecule allows surgeons to detect tumor nodules of small size very easily, in real-time, during surgery (shown in animals).

Conditions

• Peritoneal Carcinomatosis

Interventions

Type	Name	Description
OTHER	SGM-101	Administration of SGM-101 prior surgery

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-06-01
• Completion: 2017-12-08
• First posted: 2016-05-26
• Last updated: 2020-10-20

Locations

1 site across 1 country: France