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Clinical studies have demonstrated that SGM-101 enables visualization of positive margins and occult lesions in colorectal, lung and pancreatic cancer surgeries, while maintaining a high safety profile.

2023

Phase:II

SGM-CLIN09 / FLUOPANCII : A performance study of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for fluorescence-guided imaging to determine local extent and resectability during surgical resection of pancreatic ductal adenocarcinoma after neoadjuvant treatment.

NCT05984810

2023

Phase:II

SGM-CLIN11 / FOCUS GREEN : Fluorescence-guided Resection Of Colorectal Liver Metastases Using SGM-101 and Indocyanine Green.

NCT05965817

2023

Phase:II

SGM-CLIN10 / SGM-T1 : SGM-101 tumor-targeted fluorescence endoscopy to enable discrimination of malignant from benign tissue in rectal polyps with suspected T1 adenocarcinoma or high grade dysplasia: a feasibility study.

NCT06280690

2021

Phase:II

SGM-CLIN07 / SGM-CBM : a feasibility study of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for the intraoperative detection of colorectal brain metastases.

NCT04755920

2020

Phase:I

SGM-CLIN06 : intraoperative molecular imaging of pulmonary nodules by SGM-101, a fluorochrome-labeled anti-carcino-embryonic antigen (cea) monoclonal antibody.

NCT04315467

2019

Phase:II

SGM-CLIN05 : an open-label, exploratory study assessing the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for the intraoperative detection of lung metastasis in colorectal cancer.

NCT04737213

2019

Phase:II/III

SGM-CLIN04 / SGM-LARRC : Multicenter, open-label, controlled, parallel arms clinical study on the performance of SGM-101, a fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody, for locally advanced and recurrent rectal cancer.

NCT04642924

2019

Phase:III

SGM-CLIN03: Multicenter, semi-blinded, randomized, controlled, parallel arms clinical study on the performance of SGM-101, a fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal antibody, for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer.

NCT03659448

2015

Phase I/II

SGM-CLIN02 : a phase I-II study assessing the safety and performance of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for the intraoperative detection of neoplastic lesions in patients with colorectal cancer or pancreatic cancer.

NCT02973672

2001

Phase:I

SGM-CLIN01 / fluocar 1 : phase I study assessing safety of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for the detection of neoplasic lesions in patients with peritoneal carcinomatosis from colorectal cancer.

NCT02784028

SGM-101 has been tested in an phase I/II trial in the Netherlands, with patients operated at Leiden University Medical Center, Catharina Ziekenhuis (Eindhoven) and Erasmus MC (Rotterdam).

Near Infrared Surgery (NIRS). Omroep Brabant/Catharina Hospital Eindhoven