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Fluorescence guidance surgery with SGM-101 patients with colorectal lung metastasis

ABSTRACT: Primary objectives: 1. To determine the feasibility of SGM-101 for intraoperative imaging of colorectal lung metastases - Concordance between fluorescent signal and tumor status of resected tissue Primary endpoints: Concordance between intraoperative fluorescence assessment of resected lesions and their histopathology in terms of both CEA expression and tumor status.

DISEASE(S): Lung Cancer Metastatic,Colorectal Cancer Metastatic,Colorectal Lung Metastases

PROVIDER: 2539239 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:To determine the phenotypic overlap between restoring miR-101 expression in bladder cancer cells and knocking down EZH2. Either control precursors, pre-miR-101, control siRNA, or EZH2 siRNA were transfected in triplicate into UM-UC-3 cells for 72 hours at a final concentration of 50 nM.

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microRNA-101 represses EZH2 in cancer

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Intraoperative molecular imaging of colorectal lung metastases with SGM-101: a feasibility study.

Project description:PurposeMetastasectomy is a common treatment option for patients with colorectal lung metastases (CLM). Challenges exist with margin assessment and identification of small nodules, especially during minimally invasive surgery. Intraoperative fluorescence imaging has the potential to overcome these challenges. The aim of this study was to assess feasibility of targeting CLM with the carcinoembryonic antigen (CEA) specific fluorescent tracer SGM-101.MethodsThis was a prospective, open-label feasibility study. The primary outcome was the number of CLM that showed a true positive fluorescence signal with SGM-101. Fluorescence positive signal was defined as a signal-to-background ratio (SBR) ≥ 1.5. A secondary endpoint was the CEA expression in the colorectal lung metastases, assessed with the immunohistochemistry, and scored by the total immunostaining score.ResultsThirteen patients were included in this study. Positive fluorescence signal with in vivo, back table, and closed-field bread loaf imaging was observed in 31%, 45%, and 94% of the tumors respectively. Median SBRs for the three imaging modalities were 1.00 (IQR: 1.00-1.53), 1.45 (IQR: 1.00-1.89), and 4.81 (IQR: 2.70-7.41). All tumor lesions had a maximum total immunostaining score for CEA expression of 12/12.ConclusionThis study demonstrated the potential of fluorescence imaging of CLM with SGM-101. CEA expression was observed in all tumors, and closed-field imaging showed excellent CEA specific targeting of the tracer to the tumor nodules. The full potential of SGM-101 for in vivo detection of the tracer can be achieved with improved minimal invasive imaging systems and optimal patient selection.Trial registrationThe study was registered in ClinicalTrial.gov under identifier NCT04737213 at February 2021.

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